Premarket Approval Decisions for July 1998

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for July 1998. This list is generated on a monthly basis.

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.

PMA Original Approvals

APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
P960011 7/16/98	BioLon™ 1% Sodium Hyaluronate Viscoelastic Surgical Aid Fluid	Bio-Technology General Corp. Iselin, NJ 08830	The device is indicated for use as a surgical aid to protect corneal endothelium during cataract extraction (extra-capsular), intraocular lens implantation and anterior segment surgery.
P960018 7/16/98	Needlyzer™ - The Needle Destroyer Model ND2	Healthcare Products Plus, Inc. Chicago, IL 60614	The device is indicated for use as a mobile sharps needle destruction device that is intended to oxidize non-coated stainless steel needles immediately after use. The device will oxidize to the hub butterfly-type needles and all needles 16-30 gauge and 4-52mm in length attached to a metal or plastic hub or a vacutainer. The device is intended to be used in hospitals and other healthcare facilities.
P970005 7/30/98	Kremer Eximer Laser System Serial No. KEA940202 for Laser in situ Keratomileusis (LASIK) for the Correction of Primary Myopia, With and Without Astigmatism	Photomed, Inc. King of Prussia, PA 19406	Approval for a single laser, Kremer Excimer Laser System Serial No. KEA940202. This device, using a 6.0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (LASIK) in patients: 1) with myopia ranging between -1.0 and -15.0 diopters (D) with or without astigmatism ranging from 0.0 D to 5.00 D; 2) who are 18 years of age or older; and 3) with stable refraction over the 1-year period prior to surgery. Note: Patients between 18 and 20 years old should not demonstrate a shift in refraction greater than 0.5D. Patients 21 years and older should not demonstrate a shift greater than 1.0 D.
P970061 7/16/98	SCIMED® RADIUS™ Coronary Stent with Delivery System	SCIMED Maple Grove, MN 55311-1566	The device is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length <30 mm) with a reference vessel diameter ranging from 2.75 mm to 4.25 mm and is intended to improve coronary luminal diameter. Long-term outcome (beyond 6 months) for this permanent implant is unknown.

APPLICATION NUMBER/
DATE of APPROVAL

DEVICE
TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION/ INDICATIONS

P960011

7/16/98

BioLon™ 1% Sodium Hyaluronate Viscoelastic Surgical Aid Fluid

Bio-Technology General Corp.

Iselin, NJ

08830

The device is indicated for use as a surgical aid to protect corneal endothelium during cataract extraction (extra-capsular), intraocular lens implantation and anterior segment surgery.

P960018

7/16/98

Needlyzer™ - The Needle Destroyer Model ND2

Healthcare Products Plus, Inc.

Chicago, IL

60614

The device is indicated for use as a mobile sharps needle destruction device that is intended to oxidize non-coated stainless steel needles immediately after use. The device will oxidize to the hub butterfly-type needles and all needles 16-30 gauge and 4-52mm in length attached to a metal or plastic hub or a vacutainer. The device is intended to be used in hospitals and other healthcare facilities.

P970005

7/30/98

Kremer Eximer Laser System Serial No. KEA940202 for Laser in situ Keratomileusis (LASIK) for the Correction of Primary Myopia, With and Without Astigmatism

Photomed, Inc.

King of Prussia, PA

19406

Approval for a single laser, Kremer Excimer Laser System Serial No. KEA940202. This device, using a 6.0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (LASIK) in patients: 1) with myopia ranging between -1.0 and -15.0 diopters (D) with or without astigmatism ranging from 0.0 D to 5.00 D; 2) who are 18 years of age or older; and 3) with stable refraction over the 1-year period prior to surgery. Note: Patients between 18 and 20 years old should not demonstrate a shift in refraction greater than 0.5D. Patients 21 years and older should not demonstrate a shift greater than 1.0 D.

P970061

7/16/98

SCIMED® RADIUS™ Coronary Stent with Delivery System

SCIMED

Maple Grove, MN

55311-1566

The device is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length <30 mm) with a reference vessel diameter ranging from 2.75 mm to 4.25 mm and is intended to improve coronary luminal diameter. Long-term outcome (beyond 6 months) for this permanent implant is unknown.

PMA Supplemental Approvals

APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
N17679/S032 7/2/98	Tetrafilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear	CooperVision Scottsville, NY 14546	Approval for the following: 1)Aspect Vision Care, Ltd., Hamble, United Kingdom as an alternate manufacturing site; 2)an alternate manufacturing \| process of fully molded; 3)a change in the initiator used in the polymerization method; and 4)expansion of the parameter range.
P790002/S019* 7/27/98	EBI Bone Healing System	Electro-Biology, Inc. Parsippany, NJ 07054-1079	Approval for revision of the indications and usage section of the labeling for Models 1200, 1020-S, 1026, and 101, to include the definition of nonunion recommended by the Orthopedic and Rehabilitation Devices Panel on April 28, 1998 and required per FDA's letter dated June 3, 1998 (i.e., "nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").
P790005/S041* 7/24/98	OrthoGen®/OsteoGen™ Implantable Bone Growth Stimulator	Electro-Biology, Inc. Parsippany, NJ 07054-1079	Approval for revision of the indications and usage section of the labeling to include the definition of nonunion recommended by the Orthopedic and Rehabilitation Devices Panel on April 28, 1998 and required per FDA's letter dated June 3, 1998 (i.e., "a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").
P790018/S032 7/1/98	Medtronic Hall™ Prosthetic Heart Valve, Models A7700 and M7700	Medtronic, Inc. Minneapolis, MN 55440	Approval to manufacture the sewing ring component of the Medtronic Hall™ Prosthetic Heart Valves with knitted polytetrafluoro-ethylene (PTFE) fabric constructed of PTFE yarn from an alternate supplier. The models affected by the change include Model A7700 (sizes 21, 23, 25, 27, 29, and 31 mm) and Model M7700 (sizes 23, 25, 27, 29, and 31 mm).
P810002/S043 7/23/98	St. Jude Medical® Mechanical Heart Valve SJM® Master Series - Polytetrafluoroethylene (PTFE) Sewing Cuff	St. Jude Medical, Inc. St. Paul, MN 55117	Approval for the SJM® Master Series, Models ATJ-503, AETJ-504, MTJ-503, and METJ-504, with a PTFE sewing cuff.
P810020/S004 7/30/98	Palacos E-Flow (Osteopal) Bone Cement		Approval for changes in the bone cement composition. The device, as modified, will be marketed under the trade name Osteopal (E-Flow) and is indicated for use as a bone cement in arthroplastic procedures of the hip, knee, and other joins to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, nonunion of fractures of the neck of the femur, sickle cell anemia, osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
P810046/S190 7/30/98	ACS Avenger™ Coronary Dilatation Catheter	Advanced Cardiovascular Systems, Inc. Santa Clara, CA 95052-8167	Approval for additional balloon sizes for the ACS Avenger™ Coronary Dilatation Catheter (quarter sizes within the range of 2.25-3.75 mm for the currently marketed 15 mm and 20 mm balloon lengths and half sizes in the range of 2.5-4.0 mm for a 25 mm balloon length).
P810055/S070* 7/15/98	Posterior Chamber and Anterior Chamber PMMA Intraocular Lenses (IOLs)	Pharmacia & Upjohn Company Pickerington, OH 43147	Approval for a new test method and specification for ethylene oxide residuals prior to product release.
P830045/S057* 7/14/98	APS III Programmer Model 3500 with Software Model 3302	St. Jude Medical Sylmar, CA 91392-9221	Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer software Model 3302 Revision C (Paragon Version 1.03).
P830045/S058* 7/14/98	APS III Programmer Model 3500 with Software Model 3302	St. Jude Medical Sylmar, CA 91392-9221	Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer software Model 3302 Revision C (Paragon Version 1.03).
P840008/S065* 7/7/98	Dornier Lithotripter Compact S with the 140f EMSE Shock Source (Dornier Compact Delta Lihtotripter)	Dornier Medical Systems, Inc. Kennesaw, GA 30144	Approval for changes to the therapy head movement capabilities, alteration of the hand held control unit, modification of the X-ray range of movement, addition of an X-ray image storage feature, ECG monitor model replacement, replacement of the charging unit, a new mounting orientation for the ultrasound arm, design changes to the patient table, a new design for the phantom support accessory, software modifications, and labeling changes. The device, as modified, will be marketed under the trade name Dornier Compact Delta Lithotripter and is indicated for fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelvic stones.
P840068/S036 7/31/98	DELTA/VISTA Model 2881 Software Application Version 1.3	Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798	Approval for an update to the Model 2881 Software Application to include the DELTA/VISTA pacemakers, series, resulting in Version 1.3 of the Model 2881 Software Application.
P850022/S011* 7/14/98	OrthoPak® Bone Growth Stimulator System	Biolectron, Inc. Hackensack, NJ 07601	Approval for the following modifications:1)The "tombstone" - No part Number a)Change of indication b)Minor grammatical corrections of labeling 2)The Physician Manual-Part Number 380-0001-0001-844 a)Change of indication b)Removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)Minor grammatical corrections of labeling 3)The Patient Manual - Part Number 380- 0002-0001-844 a)change of indication b)removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)added the section "Electrode Retainers" (copied \| from Physician Manual) f)Minor grammatical corrections. The indication change listed above in each section is as follows: removal of the reference to a nine month clinical study time in the approved labels ("A non-union is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visible progressives signs of healing for a minimum of 3 months - no change in fracture callus") and to insert language as suggested in the FDA letter of June 3, 1998 ("A nonunion is considered to be established when the fracture site shown no visible progressive signs of healing").
P850079/S029 7/2/98	Frequency™ 55 and Frequency™ 55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear	CooperVision Irvine, CA 92718	Approval for spherical and toric configurations (clear and visibility tinted) of methafilcon A hydrophilic contact lenses for extended wear manufactured by a cast-molding process by Aspect Vision Care, Ltd., Hamble, United Kingdom.
P860007/S020* 7/6/98	Intertach II, Model 262-16	Sulzer Intermedics, Inc. Angleton, TX 77515	Approval for alternate Polyethylene Terephthalate Glycol (PETG) packaging material for the Intertach II, Model 262-16 pulse generator.
P860019/S136 7/29/98	SCIMED® PTCA Catheters	SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for a manufacturing site located at SCIMED Life Systems, Inc., 2 SCIMED Place, Maple Grove, Minnesota 55311.
P860019/S145* 7/10/98	SCIMED® Quantum Ranger™ PTCA Catheter	Scimed Life Systems, Inc. Maple Grove, MN 55311-1566	Approval to extend the product line of the SCIMED® Quantum Ranger™ PTCA Catheter to include additional balloon lengths of 9 mm, 16 mm, and 18 mm with balloon diameters ranging from 2.5 mm to 4.0 mm in 0.25 mm increments and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P880070/S008* 7/15/98	Posterior Chamber and Anterior Chamber PMMA Intraocular Lenses (IOLs)	Pharmacia & Upjohn Company Pickerington, OH 43147	Approval for a new test method and specification for ethylene oxide residuals prior to product release.
P880086/S048* 7/14/98	APS III Programmer Model 3500 with Software Model 3302	St. Jude Medical Sylmar, CA 91392-9221	Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer software Model 3302 Revision C (Paragon Version 1.03).
P880086/S049* 7/14/98	APS III Programmer Model 3500 with Software Model 3302	St. Jude Medical Sylmar, CA 91392-9221	Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer software Model 3302 Revision C (Paragon Version 1.03).
P880091/S011 7/20/98	ELASTIMIDE™ Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lenses, Models AQ-1016V, AQ-2003V, AQ-2013V, AQ-2010V, and AQ-2017V	Staar Surgical Company Monrovia, CA 91016	Approval to package the MicroSTAAR injector cartridges with the ELASTIMIDE™ lenses, and for a five-year shelf life for the cartridges sterilized via your new ethylene oxide (EtO) cycle.
P900007/S001 7/8/98	Cook Chorionic Villus Sampling (CVS) Set	Cook Ob/Gyn Spencer, IN 47460	Approval for removing the condition of approval regarding collection of individual outcome data from each CVS case.
P910066/S009* 7/14/98	Orthologic 1000 Bone Growth Stimulator	Orthologic Corporation Tempe, AZ 85281	Approval for marketing circular.
P910077/S023 7/31/98	DELTA/VISTA Model 2881 Software Application Version 1.3	Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798	Approval for an update to the Model 2881 Software Application to include the DELTA/VISTA pacemakers, series, resulting in Version 1.3 of the Model 2881 Software Application.
P920023/S004 7/15/98	UroLume® Endourethral Prosthesis- Recurrent Bulbar Urethral Strictures Application, and UreLume® Endourethral Prosthesis-Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy (BPH) Application	American Medical Systems, Inc. Minnetonka, MN 55343	Approval to: 1)increase the number or investigational sites in the post-approval study of new patients (post-approval study#2) under the recurrent bulbar urethral strictures application, and 2) increase the patient enrollment limit to 132 (to include 57 original and 75 new patients) for the post-approval study of the BPH application.
P920023/S005* 7/7/98	UroLume® Endourethral Prosthesis – Recurrent Bulbar Urethral Strictures Application, and UroLume® Endourethral Prosthesis – Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy (BPH) Application	American Medical Systems, Inc. Minnetonka, MN 55343	Approval to add a new contraindication regarding fracture distraction defects of the posterior urethra to the labeling of the UroLume® stricture application. In addition, modification of the labeling of the stricture and BPH applications to clarify that the UroLume® is not intended for temporary use.
P930036/S001* 7/15/98	ACS:Centaur AFP	Chiron Diagnostics Corporation Medfield, MA 02052-1688	Approval to add the existing AFP assay performed on the ACS:180 to a new generation of instrumentation, the Centaur and is indicated for the quantitative determination of alpha-fetoprotein (AFP) in the following:human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, as an aid in detecting open neura tube defects (NTDs) when used in conjunction with ultrasonography and amniography testing, using the Chiron Diagnostics ACS:Centaur™ Automated Chemiluminescence System.
P930038/S016 7/17/98	Angio-Seal Hemostatic Puncture Closure Device	Sherwood Davis & Geck Bothell, WA 98021-8906	Approval for labeling changes intended to minimize the occurrence of vessel occlusion events associated with use of the device.
P940005/S002 7/21/98	HDI 3000® Ultrasound system with L12-5 Scanhead	Advanced Technology Laboratories Bothell, WA 98041-3003	Approval for design change from HDI 3000® Ultrasound System with L10-5 Scanhead to HDI 3000® Ultrasound System with L12-5 Scanhead for the indication of an adjunct of mammography and physical breast examination, to provide a high degree of physician confidence in differentiating benign from malignant or suspicious breast lesions. This device provides the physician with additional information to guide a biopsy decision. Utility of this system has been demonstrated for lesions with an indeterminate Level of Suspicion (LOS 2-4) by conventional diagnostic modalities. Using the HDI system in the evaluation of solid mass characteristics can reduce the number of biopsies performed on indeterminate lesions.
P940031/S015* 7/24/98	Discover/Meridian Pacemaker Systems	Guidant Corporation St. Paul, MN 55112-5798	Approval for a modification to the specification of the "runaway" rate for the above referenced families of pacemakers from 220± 10% to 205± 5%.
P950005/S002 7/22/98	Cordis Webster Diagnostic/Ablation Deflectable Tip Catheter	Cordis Webster, Inc. Baldwin Park, CA 91706	Approval for the 7 Fr and 8 Fr braided tip version of the Diagnostic/ Ablation Deflectable Tip Catheter (with and without temperature sensors).
P950035/S002 7/28/98	NeuroControl Freehand System	NeuroControl Corporation Cleveland, OH 44106-4720	Approval for revised manufacturing procedures, revised labeling for the clinician, and revised patient labeling.
P950042/S001 7/21/98	Xillix LIFE-Lung Fluorescence Endoscopy System	Xillix Technologies Corporation Washington, D.C. 20004-1109	Approval to amend the post-market study. A third investigator will be added to assist in collecting sets of images which will be used to produce the "test set" of images for the reproducibility testing.
P960043/S008 7/17/98	Techstar® and Prostar® XL Percutaneous Vascular Surgical (PVS) Systems	Perclose, Inc. Menlo Park, CA 94025	Approval for revised labeling and training materials including, the PVS Guidelines for post-procedural care and the training video entitled PVS Post Procedure Care.
P970004/S002 7/8/98	Medtronic® Interstim® Continence Control System (Medtronic® Model 3023 Implantable Pulse Generator (IPG), Model 3031 Patient Programmer with Model 7440 Optional Antenna, and Model 3051 Software Cartridge Memory Module (MemMod®))	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for marketing the Medtronic InterStim® Model 3023 Implantable Pulse Generator (IPG) and its control devices (Model 3031 Patient Programmer with Model 7440 Optional antenna and Model 3051 Software Cartridge Memory Module (MemMod®) and is indicated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments.
P970008/S006 7/27/98	Urologix Targis™ System	Urologix, Inc. Minneapolis, MN 55447	Approval for an expansion of the indication for use statement to include relief of obstruction. The indication for use, as modified, is "The Urologix Targis System is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethra lengths of 30 to 50 mm.
P970008/S007* 7/7/98	Urologix Targis™ System, Targis™ Patient Comfort Kit	Urologix, Inc. Minneapolis, MN 55447	Approval for the Targis™ Patient Comfort Kit which includes the MDS Holder and Knee Cushions.
P970008/S008* 7/17/98	Urologix Targis™ System	Urologix, Inc. Minneapolis, MN 55447	Approval for a change in the design of the capacitor used in the antenna within the MDS catheter.
P970019/S002 7/14/98	HEALTHTRONICS LithoTron™ Lithotripsy System	HEALTHTRONICS Marietta, GA 30067	Approval for non-synchronized shockwave delivery.
P970036/S002 7/29/98	NiC2800 Needle Disposal System	NIC Limited Los Altos, CA 94024	Approval to market a battery operated version of the NiC 1800 Needle Disposal System. The device, as modified, will be marketed under the trade name NiC 2800 Needle Disposal System and is indicated for the disposal of standard plastic syringe mounted hypodermic needles (19-28 gauge/up to 2" in length) in patient treatment and clinical laboratory settings.
P970044/S002 7/10/98	Urowave® Microwave Thermotherapy System (Mobile/Transportable)	Dornier Medical Systems, Inc. Kennesaw, GA 30144	Approval for a mobile/transportable Urowave®.
P970051/S002 7/22/98	Nucleus C124M Cochlear Implant System	Cochlear Corporation Englewood, CO 80112	Approval for two minor design changes to the ESPrit (ear level) speech processor: 1) the addition of a 47µF capacitor; and 2) the lowering of the crystal Q with insertion of a low value resistor (R3-120W ). As stated in the submission and described in the telephone conference on July 22, 1998, these two changes have been tested and validated. With reference to item), this change would lower the total harmonic distortion resulting in improved audio signal. In item 2) you would improve the oscillator stability over a specified temperature range resulting in better production yield.

APPLICATION NUMBER/
DATE of APPROVAL

DEVICE
TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION/ INDICATIONS

N17679/S032

7/2/98

Tetrafilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear

CooperVision

Scottsville, NY

14546

Approval for the following: 1)Aspect Vision Care, Ltd., Hamble, United Kingdom as an alternate manufacturing site; 2)an alternate manufacturing | process of fully molded; 3)a change in the initiator used in the polymerization method; and 4)expansion of the parameter range.

P790002/S019*

7/27/98

EBI Bone Healing System

Electro-Biology, Inc.

Parsippany, NJ

07054-1079

Approval for revision of the indications and usage section of the labeling for Models 1200, 1020-S, 1026, and 101, to include the definition of nonunion recommended by the Orthopedic and Rehabilitation Devices Panel on April 28, 1998 and required per FDA's letter dated June 3, 1998 (i.e., "nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").

P790005/S041*

7/24/98

OrthoGen®/OsteoGen™ Implantable Bone Growth Stimulator

Electro-Biology, Inc.

Parsippany, NJ

07054-1079

Approval for revision of the indications and usage section of the labeling to include the definition of nonunion recommended by the Orthopedic and Rehabilitation Devices Panel on April 28, 1998 and required per FDA's letter dated June 3, 1998 (i.e., "a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").

P790018/S032

7/1/98

Medtronic Hall™ Prosthetic Heart Valve, Models A7700 and M7700

Medtronic, Inc.

Minneapolis, MN

55440

Approval to manufacture the sewing ring component of the Medtronic Hall™ Prosthetic Heart Valves with knitted polytetrafluoro-ethylene (PTFE) fabric constructed of PTFE yarn from an alternate supplier. The models affected by the change include Model A7700 (sizes 21, 23, 25, 27, 29, and 31 mm) and Model M7700 (sizes 23, 25, 27, 29, and 31 mm).

P810002/S043

7/23/98

St. Jude Medical® Mechanical Heart Valve SJM® Master Series - Polytetrafluoroethylene (PTFE) Sewing Cuff

St. Jude Medical, Inc.

St. Paul, MN

55117

Approval for the SJM® Master Series, Models ATJ-503, AETJ-504, MTJ-503, and METJ-504, with a PTFE sewing cuff.

P810020/S004

7/30/98

Palacos E-Flow (Osteopal) Bone Cement

Approval for changes in the bone cement composition. The device, as modified, will be marketed under the trade name Osteopal (E-Flow) and is indicated for use as a bone cement in arthroplastic procedures of the hip, knee, and other joins to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, nonunion of fractures of the neck of the femur, sickle cell anemia, osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.

P810046/S190

7/30/98

ACS Avenger™ Coronary Dilatation Catheter

Advanced Cardiovascular Systems, Inc.

Santa Clara, CA

95052-8167

Approval for additional balloon sizes for the ACS Avenger™ Coronary Dilatation Catheter (quarter sizes within the range of 2.25-3.75 mm for the currently marketed 15 mm and 20 mm balloon lengths and half sizes in the range of 2.5-4.0 mm for a 25 mm balloon length).

P810055/S070*

7/15/98

Posterior Chamber and Anterior Chamber PMMA Intraocular Lenses (IOLs)

Pharmacia & Upjohn Company

Pickerington, OH

43147

Approval for a new test method and specification for ethylene oxide residuals prior to product release.

P830045/S057*

7/14/98

APS III Programmer Model 3500 with Software Model 3302

St. Jude Medical

Sylmar, CA

91392-9221

Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer software Model 3302 Revision C (Paragon Version 1.03).

P830045/S058*

7/14/98

APS III Programmer Model 3500 with Software Model 3302

St. Jude Medical

Sylmar, CA

91392-9221

P840008/S065*

7/7/98

Dornier Lithotripter Compact S with the 140f EMSE Shock Source (Dornier Compact Delta Lihtotripter)

Dornier Medical Systems, Inc.

Kennesaw, GA

30144

Approval for changes to the therapy head movement capabilities, alteration of the hand held control unit, modification of the X-ray range of movement, addition of an X-ray image storage feature, ECG monitor model replacement, replacement of the charging unit, a new mounting orientation for the ultrasound arm, design changes to the patient table, a new design for the phantom support accessory, software modifications, and labeling changes. The device, as modified, will be marketed under the trade name Dornier Compact Delta Lithotripter and is indicated for fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelvic stones.

P840068/S036

7/31/98

DELTA/VISTA Model 2881 Software Application Version 1.3

Guidant Corporation

Cardiac Pacemakers (CPI)

St. Paul, MN

55112-5798

Approval for an update to the Model 2881 Software Application to include the DELTA/VISTA pacemakers, series, resulting in Version 1.3 of the Model 2881 Software Application.

P850022/S011*

7/14/98

OrthoPak® Bone Growth Stimulator System

Biolectron, Inc.

Hackensack, NJ

07601

Approval for the following modifications:1)The "tombstone" - No part Number a)Change of indication b)Minor grammatical corrections of labeling 2)The Physician Manual-Part Number 380-0001-0001-844 a)Change of indication b)Removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)Minor grammatical corrections of labeling 3)The Patient Manual - Part Number 380- 0002-0001-844 a)change of indication b)removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)added the section "Electrode Retainers" (copied | from Physician Manual) f)Minor grammatical corrections. The indication change listed above in each section is as follows: removal of the reference to a nine month clinical study time in the approved labels ("A non-union is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visible progressives signs of healing for a minimum of 3 months - no change in fracture callus") and to insert language as suggested in the FDA letter of June 3, 1998 ("A nonunion is considered to be established when the fracture site shown no visible progressive signs of healing").

P850079/S029

7/2/98

Frequency™ 55 and Frequency™ 55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

CooperVision

Irvine, CA

92718

Approval for spherical and toric configurations (clear and visibility tinted) of methafilcon A hydrophilic contact lenses for extended wear manufactured by a cast-molding process by Aspect Vision Care, Ltd., Hamble, United Kingdom.

P860007/S020*

7/6/98

Intertach II, Model 262-16

Sulzer Intermedics, Inc.

Angleton, TX

77515

Approval for alternate Polyethylene Terephthalate Glycol (PETG) packaging material for the Intertach II, Model 262-16 pulse generator.

P860019/S136

7/29/98

SCIMED® PTCA Catheters

SCIMED Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for a manufacturing site located at SCIMED Life Systems, Inc., 2 SCIMED Place, Maple Grove, Minnesota 55311.

P860019/S145*

7/10/98

SCIMED® Quantum Ranger™ PTCA Catheter

Scimed Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval to extend the product line of the SCIMED® Quantum Ranger™ PTCA Catheter to include additional balloon lengths of 9 mm, 16 mm, and 18 mm with balloon diameters ranging from 2.5 mm to 4.0 mm in 0.25 mm increments and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

P880070/S008*

7/15/98

Posterior Chamber and Anterior Chamber PMMA Intraocular Lenses (IOLs)

Pharmacia & Upjohn Company

Pickerington, OH

43147

Approval for a new test method and specification for ethylene oxide residuals prior to product release.

P880086/S048*

7/14/98

APS III Programmer Model 3500 with Software Model 3302

St. Jude Medical

Sylmar, CA

91392-9221

P880086/S049*

7/14/98

APS III Programmer Model 3500 with Software Model 3302

St. Jude Medical

Sylmar, CA

91392-9221

P880091/S011

7/20/98

ELASTIMIDE™ Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lenses, Models AQ-1016V, AQ-2003V, AQ-2013V, AQ-2010V, and AQ-2017V

Staar Surgical Company

Monrovia, CA

91016

Approval to package the MicroSTAAR injector cartridges with the ELASTIMIDE™ lenses, and for a five-year shelf life for the cartridges sterilized via your new ethylene oxide (EtO) cycle.

P900007/S001

7/8/98

Cook Chorionic Villus Sampling (CVS) Set

Cook Ob/Gyn

Spencer, IN

47460

Approval for removing the condition of approval regarding collection of individual outcome data from each CVS case.

P910066/S009*

7/14/98

Orthologic 1000 Bone Growth Stimulator

Orthologic Corporation

Tempe, AZ

85281

Approval for marketing circular.

P910077/S023

7/31/98

DELTA/VISTA Model 2881 Software Application Version 1.3

Guidant Corporation

Cardiac Pacemakers (CPI)

St. Paul, MN

55112-5798

Approval for an update to the Model 2881 Software Application to include the DELTA/VISTA pacemakers, series, resulting in Version 1.3 of the Model 2881 Software Application.

P920023/S004

7/15/98

UroLume® Endourethral Prosthesis- Recurrent Bulbar Urethral Strictures Application, and UreLume® Endourethral Prosthesis-Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy (BPH) Application

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval to: 1)increase the number or investigational sites in the post-approval study of new patients (post-approval study#2) under the recurrent bulbar urethral strictures application, and 2) increase the patient enrollment limit to 132 (to include 57 original and 75 new patients) for the post-approval study of the BPH application.

P920023/S005*

7/7/98

UroLume® Endourethral Prosthesis – Recurrent Bulbar Urethral Strictures Application, and UroLume® Endourethral Prosthesis – Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy (BPH) Application

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval to add a new contraindication regarding fracture distraction defects of the posterior urethra to the labeling of the UroLume® stricture application. In addition, modification of the labeling of the stricture and BPH applications to clarify that the UroLume® is not intended for temporary use.

P930036/S001*

7/15/98

ACS:Centaur AFP

Chiron Diagnostics Corporation

Medfield, MA

02052-1688

Approval to add the existing AFP assay performed on the ACS:180 to a new generation of instrumentation, the Centaur and is indicated for the quantitative determination of alpha-fetoprotein (AFP) in the following:human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, as an aid in detecting open neura tube defects (NTDs) when used in conjunction with ultrasonography and amniography testing, using the Chiron Diagnostics ACS:Centaur™ Automated Chemiluminescence System.

P930038/S016

7/17/98

Angio-Seal Hemostatic Puncture Closure Device

Sherwood Davis & Geck

Bothell, WA

98021-8906

Approval for labeling changes intended to minimize the occurrence of vessel occlusion events associated with use of the device.

P940005/S002

7/21/98

HDI 3000® Ultrasound system with L12-5 Scanhead

Advanced Technology Laboratories

Bothell, WA

98041-3003

Approval for design change from HDI 3000® Ultrasound System with L10-5 Scanhead to HDI 3000® Ultrasound System with L12-5 Scanhead for the indication of an adjunct of mammography and physical breast examination, to provide a high degree of physician confidence in differentiating benign from malignant or suspicious breast lesions. This device provides the physician with additional information to guide a biopsy decision. Utility of this system has been demonstrated for lesions with an indeterminate Level of Suspicion (LOS 2-4) by conventional diagnostic modalities. Using the HDI system in the evaluation of solid mass characteristics can reduce the number of biopsies performed on indeterminate lesions.

P940031/S015*

7/24/98

Discover/Meridian Pacemaker Systems

Guidant Corporation

St. Paul, MN

55112-5798

Approval for a modification to the specification of the "runaway" rate for the above referenced families of pacemakers from 220± 10% to 205± 5%.

P950005/S002

7/22/98

Cordis Webster Diagnostic/Ablation Deflectable Tip Catheter

Cordis Webster, Inc.

Baldwin Park, CA

91706

Approval for the 7 Fr and 8 Fr braided tip version of the Diagnostic/ Ablation Deflectable Tip Catheter (with and without temperature sensors).

P950035/S002

7/28/98

NeuroControl Freehand System

NeuroControl Corporation

Cleveland, OH

44106-4720

Approval for revised manufacturing procedures, revised labeling for the clinician, and revised patient labeling.

P950042/S001

7/21/98

Xillix LIFE-Lung Fluorescence Endoscopy System

Xillix Technologies Corporation

Washington, D.C.

20004-1109

Approval to amend the post-market study. A third investigator will be added to assist in collecting sets of images which will be used to produce the "test set" of images for the reproducibility testing.

P960043/S008

7/17/98

Techstar® and Prostar® XL Percutaneous Vascular Surgical (PVS) Systems

Perclose, Inc.

Menlo Park, CA

94025

Approval for revised labeling and training materials including, the PVS Guidelines for post-procedural care and the training video entitled PVS Post Procedure Care.

P970004/S002

7/8/98

Medtronic® Interstim® Continence Control System (Medtronic® Model 3023 Implantable Pulse Generator (IPG), Model 3031 Patient Programmer with Model 7440 Optional Antenna, and Model 3051 Software Cartridge Memory Module (MemMod®))

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for marketing the Medtronic InterStim® Model 3023 Implantable Pulse Generator (IPG) and its control devices (Model 3031 Patient Programmer with Model 7440 Optional antenna and Model 3051 Software Cartridge Memory Module (MemMod®) and is indicated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments.

P970008/S006

7/27/98

Urologix Targis™ System

Urologix, Inc.

Minneapolis, MN

55447

Approval for an expansion of the indication for use statement to include relief of obstruction. The indication for use, as modified, is "The Urologix Targis System is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethra lengths of 30 to 50 mm.

P970008/S007*

7/7/98

Urologix Targis™ System, Targis™ Patient Comfort Kit

Urologix, Inc.

Minneapolis, MN

55447

Approval for the Targis™ Patient Comfort Kit which includes the MDS Holder and Knee Cushions.

P970008/S008*

7/17/98

Urologix Targis™ System

Urologix, Inc.

Minneapolis, MN

55447

Approval for a change in the design of the capacitor used in the antenna within the MDS catheter.

P970019/S002

7/14/98

HEALTHTRONICS LithoTron™ Lithotripsy System

HEALTHTRONICS

Marietta, GA

30067

Approval for non-synchronized shockwave delivery.

P970036/S002

7/29/98

NiC2800 Needle Disposal System

NIC Limited

Los Altos, CA

94024

Approval to market a battery operated version of the NiC 1800 Needle Disposal System. The device, as modified, will be marketed under the trade name NiC 2800 Needle Disposal System and is indicated for the disposal of standard plastic syringe mounted hypodermic needles (19-28 gauge/up to 2" in length) in patient treatment and clinical laboratory settings.

P970044/S002

7/10/98

Urowave® Microwave Thermotherapy System (Mobile/Transportable)

Dornier Medical Systems, Inc.

Kennesaw, GA

30144

Approval for a mobile/transportable Urowave®.

P970051/S002

7/22/98

Nucleus C124M Cochlear Implant System

Cochlear Corporation

Englewood, CO

80112

Approval for two minor design changes to the ESPrit (ear level) speech processor: 1) the addition of a 47µF capacitor; and 2) the lowering of the crystal Q with insertion of a low value resistor (R3-120W ). As stated in the submission and described in the telephone conference on July 22, 1998, these two changes have been tested and validated. With reference to item), this change would lower the total harmonic distortion resulting in improved audio signal. In item 2) you would improve the oscillator stability over a specified temperature range resulting in better production yield.

APPLICATION NUMBER & LTR DATE	DEVICE NAME	COMPANY NAME	COMMENTS
P790020/S058 7/9/98**	Sauflon® 70 (LL-70) Lidofilcon A soft (hydrophilic) Contact Lens	Allergan, Inc. Irvine, CA 92623-9534	Requested the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.
P810002/S047 7/14/98**	St. Jude Medical Mechanical Heart Valve with a PTFE Sewing Cuff	St. Jude Medical, Inc. St. Paul, MN 55117	The 30 day requested a PTFE fabric supplier change.
P840031/S009 7/9/98**	LL-79 Lidofilcon B (hydrophilic) Contact Lens	Biocompatibles Eyecare, Inc. Norfolk, VA 23507	The 30-day Notice requested that the device, which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.
P870072/S007 7/20/98**	Thoratec Ventricular Assist Device (VAD) System	Thoratec Laboratories Pleasanton, CA 94588	Requested change in the supplier of the valves used to control the direction of blood flow in the Ventricular Assist Device. The supplier will be changed from Sorin biomedical in Irvine, California to Arrow International in Reading Pennsylvania.
P890003/S057 7/14/98**	Thera I Models of Implantable Pulse Generators	Medtronic, Inc. Minneapolis, MN 55432-3576	Requested a change in the application pattern of the epoxy area that affixes the device battery to the insulator cup, and an epoxy bead or fillet will be added between the battery and the hybrid.
P950032/S001 7/9/98**	Apligraf™ (Graftskin)	Organogenesis, inc. Canton, MA 02021	The 30-day Notice requested a manufacturing process change for Apligraf™ . The requested change will replace 8 laboratory-scale incubators currently used in the Apligraf™ manufacturing process, FORMA Steri-Cult 200, model #3033, with 6 production-scale incubators manufactured by Lunaire Corporation (model # CI0641W-6SPL). The change will require a lower temperature setpoint in the Lunaire incubators during manufacturing.
P960039/S001 7/9/98**	Soft-55 EW Aphakic Vifilcon A (hydrophilic) Contact Lens	Biocompatibles Eyecare, Inc. Norfolk, VA 23507	The 30-day Notice requested that the device, which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.
P970012/S003 7/14/98**	Kappa 400 Models of Implantable Pulse Generators	Medtronic, Inc. Minneapolis, MN 55432	Requested a change in the application pattern of the epoxy area that affixes the device battery to the insulator cup, and an epoxy bead or fillet will be added between the battery and the hybrid.
P970035/S003 7/10/98**	Micro Stent II Over-the-wire Coronary Stent System/GFX Over-the-wire Coronary Stent System	Arterial Vascular Engineering, Inc. Santa Rosa, CA 95403	Requested a revision in the Installation Qualification (IQ) and Operational Qualification (OQ) validations for the Strain Relief Equipment, as well as a revision in the preventative maintenance procedure for Strain Relief Equipment to include monthly wire integrity verification.

Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 42

Summary of PMA Originals Under Review
Total Under Review: 73
Total Active: 37
Total On Hold: 36
Number Greater Than 180 Days: 4

Summary of PMA Supplements Under Review
Total Under Review: 228
Total Active: 154
Total On Hold: 74
Number Greater Than 180 Days: 5

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 42
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 78
Number Greater Than 180 Days: 2

PMA Final Decisions Rendered for July 1998

PMA Original Approvals

PMA Supplemental Approvals