FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

PMA Final Decisions Rendered for February 2001

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
P990043 2/8/01	DiaSorin ETI-EBK PLUS ASSAY	DiaSorin, Inc. Stillwater, MN 55082	Approval for the DiaSorin ETI-EBK PLUS Assay. The device is indicated for the qualitative detection of hepatitis Be antigen (HBeAg) in human serum or plasma (EDTA, citrate or heparin). The ETI-EBK PLUS is intended for manual use and with the Biochem Immunosystems Labotech/ETI-Lab automated instrument. The detection of HBeAg is indicative of active HBV replication, usually correlating with viremia. A reactive test is presumptive laboratory evidence for infection with hepatitis B virus (HBV). Further HBV serological marker testing is required to define the specific disease state. The HBeAg assay’s performance has not been established for the monitoring of HBV disease or therapy.
P990085 2/16/01	VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lenses (Clear and Visibility Tinted with UV Blocker) for Extended Wear	VISTAKON, Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32247	Approval for the VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lenses (Clear and Visibility Tinted with UV Blocker) for Extended Wear. Indications include: 1) The VISTAKON Spherical (lenefilcon A) Contact Lens is indicated for daily and extended wear for the correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes. The lens is indicated for daily wear in aphakic persons. The lens may be worn by persons who have astigmatism of 1.00 diopter or less which does not interfere with visual acuity. 2) The VISTAKON BIFOCAL (lenefilcon A) Contact Lens is indicated for daily and extended wear for the correction of distance and near vision in presbyopic not-aphakic persons with non-diseased eyes. The lens is indicated for daily wear in aphakic persons. The lens may be worn by persons who have astigmatism of 1.00 diopter or less which does not interfere with visual acuity. 3) The VISTAKON TORIC (lenefilcon A) Contact Lens is indicated for daily and extended wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and have 10.00 diopters or less of astigmatism. The lens is indicated for daily wear in aphakic persons. 4) The VISTAKON TORIC BIFOCAL (lenefilcon A) Contact Lens is indicated for daily and extended wear for the correction of distance and near vision in presbyopic not-aphakic persons with non-diseased eyes that have astigmatism of 10.00 diopters or less. The lens is indicated for daily wear in aphakic persons. 5) VISTAKON (lenefilcon A) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses may be prescribed for either daily wear or extended wear from 1-7 days between removals for cleaning and disinfection or disposal, as recommended by the eye care practitioner. Eye care practitioners may prescribe the lens either for single-use disposable wear or frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system recommended for soft (hydrophilic) contact lenses.
P000007 2/27/01	Edwards Prima™ Plus Stentless Bioprosthesis Model 2500P	Edwards Lifesciences LLC Irvine, CA 92614	Approval for the Edwards Prima™ Plus Stentless Bioprosthesis Model 2500P, sizes 21, 23, 25 and 27 mm. The device is indicated for patients who require replacement of their native or prosthetic aortic valve using the subcoronary implantation technique.
P000016 2/9/01	Corometrics Model 120 F-Series Maternal/Fetal Monitor with Integrated Fetal Oxygen Saturation Monitoring, Corometrics Fetal Patient Module, and the Nellcor OxiFirst™ FS14 Sensor	GE Medical Systems Information Technologies Wallingford, CT 06492	Approval for the Corometrics Model 120 F-Series Maternal/Fetal Monitor with Integrated Fetal Oxygen Saturation Monitoring, Corometrics Fetal Patient Module, and the Nellcor OxiFirst™ FS14 Sensor. The 120 F-Series system continuously monitors intrapartum fetal oxygen saturation (FspO2) and is indicated as an adjunct to fetal heart rate (FHR) monitoring in the presence of a nonreassuring fetal heart rate pattern. It should only be used after maternal membranes have ruptured and on a singleton fetus in vertex presentation with a gestational age greater than or equal to 36 weeks.
P000035 2/27/01	TMJ Fossa-Eminence Prosthesis™	TMJ Implants, Inc. Golden, CO 80401	Approval for the TMJ Fossa-Eminences Prosthesis™. The device is indicated for use in treatment of severe temporomandibular joint disease due to: 1) Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment, 2) Recurrent fibrosis and/or bony ankylosis not responsive to other modalities of treatment, 3) Failed tissue graft, 4) Failed alloplastic joint reconstruction, 5) Internal Derangement confirmed to be pathological in origin by both clinical observation and radiographic findings, where the patient has moderate to severe pain and/or disabling dysfunction and has not responded to less invasive conventional therapy.

 

PMA/PDP SUPPLEMENTAL APPROVALS
APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P840001/S047 2/21/01 180-Day	Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ Spinal Cord Stimulation Systems	Medtronic Neurological Minneapolis, MN 55421	Approval for expansion of the Indications for Use of the Medtronic Model 7421 Itrel, 7424 Itrel II, 7425 Itrel III and Model 7427 Synergy Spinal Cord Stimulation Systems. These devices are now indicated "as an aid in the management of chronic intractable pain of the trunk or limbs, including unilateral or bilateral pain associated with the following: failed back syndrome or low back syndrome of failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, post-laminectomy pain, multiple back operations, unsuccessful disc surgery, degenerative disc disease (DDD)/herniated disc pain refractory to conservative and surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, complex regional pain syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia"
P840064/S022 2/13/01 Special	VISCOAT® Sodium Hyaluronate	Alcon Research Fort Worth, TX 76134	Approval for labeling changes that add two precautionary statements to the VISCOAT solution and DUOVISC system labeling insert.
P870048/S008 2/2/01 180-Day	EBK RIA Assay/ETI-EBK	DiaSorin S.r.l. Saluggia (VC), Italy 13040	Approval for a change in the Negative and Positive Controls and the Neutralizing Solutions from defibrinated plasma to serum and a change in the purification process and shelf life of some components of the EBK device and the ETI-EBK device.
P890014/S003 2/2/01 180-Day	HA-IGMK RIA Assay/ETI-HA-IGMK Plus	DiaSorin S.r.l. Saluggia (VC), Italy 13040	Approval for a change in the storage conditions and purification process of some components of the HA-IGMK RIA device, and the ETI-HA-IGMK Plus device.
P890019/S006 2/2/01 180-Day	AB-HAVK RIA Assay/ETI-AB-HAVK Plus	DiaSorin S.r.l. Saluggia (VC), Italy 13040	Approval for a change in the purification process and storage conditions of components of the AB-HAVK RIA device and the ETI-AB-HAVK Plus device.
P890047/S013 2/13/01 Special	DUOVISC Labeling Insert for PROVISC® Sodium Hyaluronate PMA	Alcon Research Fort Worth, TX 76134	Approval for labeling changes that add two precautionary statements to the DUOVISC system labeling insert.
P900009/S012 2/21/01 180-Days	Exogen 3000® Sonic Accelerated Fracture Healing System	Exogen, Inc. Piscataway, NJ 08855	Approval for a change in labeling for the Exogen 3000®, to incorporate both the fresh fracture and nonunion information into one set of Physician’s Instructions for Use, Patient’s Instructions for Use, and Product Insert Bulletin; to make manual size and formatting changes, and to add nonunion background information.
P900043/S025 2/2/01 180-Days	BX VELOCITY™ Stent with Raptor™ Over-the-Wire Delivery System	Cordis Corporation Warren, NJ 07059	Approval for a new indication (i.e., de novo and restenotic lesions) and additional stent diameters (i.e., 4.5 and 5.0 mm) for the BX VELOCITY™ Stent with Raptor™ Over-the-Wire Delivery System. The device, as modified, is now indicated for improving coronary luminal diameter in the following: 1) for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (£ 30 mm in length) in native coronary arteries with reference diameters ranging from 3.0 mm to 5.0 mm; and 2) for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (£ 30 mm in length) with reference diameters in the range of 2.25 mm to 4.00 mm. The 2.25 mm, 2.5 mm, and 2.75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4.5 and 5.0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.
P920015/S020 2/5/01 Real-Time	Medtronic Model 6725 Pin-plug Kit	Medtronic, Inc. Shoreview, MN 55126	Approval for the Medtronic Model 6725 Pin-plug Kit.
P940031/S025 2/26/01 Real-Time	Discovery/Meridian Pacing System	Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112	Approval for the introduction of the PDM Software Application Model 28990 version 4.3.
P950008/S002 2/8/01 Real-Time	SILIKON™ 1000	Alcon Laboratories Fort Worth, TX 76134	Approval for change of stopper for the container/closure system for SILIKON™ 1000.
P950029/S013 2/2/01 Real-Time	Brio, Talent, and Opus Pacemakers and Programmer Software	ELA Medical Plymouth, MN 55441	Approval for a new digital pacing chip, the Logauto H5, Brio and Talent firmware Mask L4, and CSO version 4.16UG programmer software.
P950037/S018 2/5/01 Real-Time	Philos Pacing System	Biotronik, Inc. Lake Oswego, OR 97035	Approval for programmer software version B-K02.V.U.
P960004/S017 2/15/01 180-Day	ThinLine II/FineLine II Sterox Pacing Leads	Guidant Corporation St. Paul, MN 55112	Approval for a manufacturing site located at Guidant Puerto Rico, B.V., Dorado, Puerto Rico. The manufacturing site will perform the sterilization, packaging and labeling of the Device.
P960025/S002 2/28/01 180-Day	Lumbar I/F Cage® with VSP Spine System	DePuy AcroMed, Inc. Raynham, MA 02767	Approval for the clinical protocol for a post-approval study.
P960040/S020 2/1/01 Real-Time	VENTAK® PRIZM™ Automatic Implantable Cardioverter Defibrillator (AICD™) Models DR Model 1851, DR/HE Model 1853, VR Models 1850/1852	Guidant Corporation St. Paul, MN 55112	Approval for the modification of the PRIZM AICD header.
P960043/S030 2/2/01 Real-Time	The Closer 6 Fr. Suture Mediated Closure (SMC) System and The Closer S 6 Fr. Suture Mediated Closure (SMC) System	Perclose, Inc. Redwood City, CA 94063	Approval for design changes to the multi-lumen structure of the sheath (from 5 lumens to 3 lumens) as well as combining the exit ramp and Pebax beading into a single injection molded Pebax component to simplify the manufacturing process. These modifications apply to both The Closer 6 Fr. SMC System and The Closer S 6 Fr. SMC System.
P960052/S001 2/15/01 Special	DERMABOND® Topical Skin Adhesive	Closure Medical Corporation Raleigh, NC 27616	Approval for labeling modifications to clarify safe use of the product.
D970003/S015 2/26/01 Real-Time	Pulsar/Pulsar Max Pacing System	Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112	Approval for the introduction of the PDM Software Application Model 28990 version 4.3.
P970003/S030 2/27/01 Real-Time	Model 250 NeuroCybernetic Prosthesis System Programming Software (Version 6)	Cyberonics, Inc. Houston, TX 77058	Approval for the System Model 250 NCP Programming Software (Version 6).
P970004/S011 2/5/01 Real-Time	InterStim System for Urinary Control, 3080/3886 Lead Kits	Medtronic, Inc. Minneapolis, MN 55421	Approval for the addition of an alternative tungsten stylet for lead kits 3080/3886 and minor changes to the labeling.
P970021/S004 2/13/01 180-Day	ThermaChoice Uterine Balloon Therapy System	Gynecare/Ethicon, Inc. Menlo Park, CA 94025	Approval to transfer the ThermaChoice catheter manufacturing operations to a new manufacturing facility located at Ethicon, Inc., Chihuahua, Mexico.
P970024/S004 2/6/01 180-Day	Lyra™ ICD Systems	Angeion Corp. St. Paul, MN 55127	Approval for the firmware modifications in the Lyra™ ICD systems.
P970042/S001 2/5/01 180-Day	Medstone STS™ Lithotripter for the Treatment of Symptomatic, Solitary, Radiolucent, Non-Calcified Gallstones	Medstone International, Inc. Aliso Viejo, CA 92656	Approval for several changes to the post-approval study protocol. Specifically, these changes are 1) changes to inclusion criteria 3 and 5, 2) changes to exclusion criteria 7, 8, 9, 10, 11, 13, 15, and 16, 3) elimination of the ultrasound evaluation immediately post-lithotripsy, 4) elimination of the oral cholecystogram at the six-month visit, and 5) addition of statements to clarify guidelines for scheduling follow-up visits and to list protocol requirements by study visit.
P970051/S014 2/8/01 Real-Time	Nucleus 24 Cochlear Implant System for Adults and Children and Nucleus 24 Contour Cochlear Implant CI24R (CS)	Cochlear Corporation Englewood, CO 80112	Approval for an extension of the shelf life from six (6) months to two (2) years.
P980001/S022 2/16/01 180-Day	NIROYAL™ Elite Over-the-Wire (OTW) Stent System	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for the NIROYAL™ Elite OTW Stent System. The device is indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length £ 25 mm) in reference vessle diameter of 3.0 to 4.0 mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2.5 to 4.0 mm; and 3) patients with symptomatic heart disease due to lesions in saphenous vein bypass grafts with lesion length £ 30 mm and reference diameter in the range of 3.0 to 4.0 mm.
P980001/S024 2/16/01 180-Day	NIR™ Elite Monorail and Over-the-Wire (OTW) Stent Systems	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for the NIR™ Elite Monorail and OTW Stent Systems. The devices are indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease associated with stenotic lesions in native coronary arteries (length £ 25 mm) in reference vessel diameter of 3.0 to 4.0 mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2.5 to 4.0 mm; and 3) patients with symptomatic heart disease due to lesions in saphenous vein bypass grafts with lesion length £ 30 mm and reference diameter in the range of 3.0 to 4.0 mm.
P980016/S013 2/22/01 180-Day	Model 9322 SmartMagnet™	Medtronic, Inc. Shoreview, MN 55126	Approval for the Model 9322 SmartMagnet™. The device, as modified, will be marketed under the trade name SmartMagnet™ and is indicated for keeping Medtronic ICDs from delivering inappropriate therapy, such as shocks, to patients during surgical procedures that require cautery or other electrically noisy devices.
P980050/S002 2/13/01 Real-Time	Medtronic GEM III AT Model 7276 Implantable Cardioverter Defibrillator with the Model 9465 Patient Assistant	Medtronic, Inc. Shoreview, MN 55126	Approval for the Medtronic GEM III AT Model 7276 Implantable Cardioverter Defibrillator with the Model 9465 Patient Assistant.
P990009/S004 2/28/01 Real-Time	FloSeal Matrix (AKA Proceed) Hemostatic Sealant	Fusion Medical Technologies, Inc. Fremont, CA 94555	Approval for an increase in an intermediate specification for residual glutaraldehyde from 20 to 40 ppm.
P990017/S012 2/15/01 180-Day	Ancure® Endograft System	Guidant Corporation Menlo Park, CA 94025	Approval for a modification to the training program to allow less than 100% case support at centers that meet the established criteria. The Change affects the conditions of approval described in the original approval order, dated September 28, 1999.
P990050/S001 2/16/01 Real-Time	Optical Biopsy™ System	SpectraScience, Inc. Minneapolis, MN 55447	Approval for two additional working lengths of optical fibers to be included with the Optical Biopsy™ System.
P990054/S001 2/15/01 Real-Time	Chilli Cooled Ablation System	Cardiac Pathways Corporation Sunnyvale, CA 94086	Approval for an accelerated aging protocol to be used to extend the shelf life of the approved devices.
P990075/S001 2/27/01 180-Day	Saline-Filled Mammary Prosthesis and Spectrum® Post-Operatively Adjustable Saline-Filled Mammary Prosthesis	Mentor Corporation Santa Barbara, CA 93111	Approval for the Mentor Saline and Spectrum Mammary Prostheses Retrieval Protocol.
P000020/S002 2/7/01 180-Day	Stinger M Ablation Catheter, Models 210001M, 210002M, 210003M, 210004M, 210005M and 210006M and TempLink M Cable, Model 210078M	C.R. Bard, Inc. Lowell, MA 01851	Approval for the Stinger M Ablation Catheter (models 210001M – 210006M) and the TempLink M Cable Model 210078M). These devices are indicated for creating focal endocardial lesions during cardiac ablation procedures to treat arrhythmias and for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli.

 

30-DAY NOTICES (135 Day Supplement Was Not Required)
APPLICATION NUMBER & LTR DATE	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	COMMENTS
P860003/S038 1/25/01	UVAR® XTS® PHOTOPHERESIS System	THERAKOS, Inc. Exton, PA 19341	Change in the use of Dymax 29048 UV curable adhesive for sealing the two acrylic photoactivation plates to using Radio Frequency Welding.
P900060/S022 2/16/01	CarboMedics® Prosthetic Heart Valve	Sulzer Carbomedics, Inc. Austin, TX 78752	Increasing the sterilization load size for CPHV™, and utilize mixed loads of CPHV™ and annuloplasty rings (AnnuloFlo®, and/or AnnuloFlex™), at the Austin and Calgary facilities.
P970020/S029 2/26/01	MULTI-LINK RX TETRA™ Coronary Stent System	Guidant Corporation Temecula, CA 92591	Manufacturing process change to the inner support mandrel in the Rapid Exchange (RX) version of the MULTI-LINK RX TETRA™ Coronary Stent System.
P980001/S028 2/21/01	NIR® Premounted Stent Systems	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Change in the acceptance criteria of a gel lump on the SOX™ component.
P000018/S007 2/13/01	Novost™ Beta-Cath™ System	Novoste Corporation Norcross, GA 30093	Change in the supplier and the manufacturing method used in forming the proprietary connector of the Beta-Cath™ Delivery Catheter, from a machined to a molded process.

 

Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 34

Summary of PMA Originals Under Review
Total Under Review: 80
Total Active: 40
Total On Hold: 40
Number Greater Than 180 Days: 0

Summary of PMA Supplements Under Review
Total Under Review: 245
Total On Hold: 94
Number Greater Than 180 Days: 1

Summary of All PMA Submissions Received
Originals: 12
Supplements: 54

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 34
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 114.5
FDA Time: 88.7 Days MFR Time: 25.8 Days

Revised 1/14/2002

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH