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

PMA Final Decisions Rendered for January 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

PMA/PDP Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P790017/S074 1/8/01 Real-Time	D114S Over-The-Wire Balloon Dilatation Catheter	Medtronic AVE, Inc. Santa Rosa, CA 95403	Approval for the addition of six (6) catalogue items to the approved D114S Over-The-Wire Balloon Dilatation Catheter product line. These six items consist of a 10 mm balloon length in each of the current balloon diameters of 1.5 mm 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, and 4.0 mm. In addition, approval for a minor dimensional change to the 1.5 mm diameter extruded balloon tubing (0.0135"/0.0205" ID/OD from the current 0.014"/0.022" ID/OD). The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P810046/S203 1/11/01 Real-Time	RX CHASSIS 1™ Coronary Dilatation Catheter	Guidant Corporation Temecula, CA 92589	Approval for the RX CHASSIS 1™ Coronary Dilatation Catheter. The device, as modified, is indicated for a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST segment elevation myocardial infarction.
P810046/S205 1/24/01 Real-Time	CrossSail™ and OpenSail™ Coronary Dilatation Catheters	Guidant Corporation Temecula, CA 92589	Approval for the revision of the CrossSail™ and OpenSail™ Coronary Dilatation Catheter’s compliance charts. These catheters are indicated for: 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction.
P840024/S080 1/16/01 180-Day	Nucleus 22 Cochlear Implant System - Adults	Cochlear Corporation Englewood, CO 80112	Approval for modification to the firmware, components and labeling of the Portable Programming System (PPS) with no change to the currently approved indications for use.
P850089/S045 1/8/01 Real-Time	Medtronic® CapSure® Novus Steroid Eluting, Bipolar, Transvenous Pacing Lead Models 5054 and 5554.	Medtronic, Inc. Shoreview, MN 55126	Approval to distribute the Medtronic® CapSure® Z Novus Models 5054 and 5554 pacing leads under a new trade name. The devices will be marketed under the trade name Vitatron Impulse II Models IHP 09B and IHP 09JB and are indicated for providing permanent pacing and sensing of the ventricle (Model IHP 09B) and atrium (Model IHP 09JB) when used with a compatible pulse generator.
P860003/S037 1/5/01 180-Day	UVAR® XTS™ Photopheresis System	Therakos Exton, PA 19341	Approval for the following software changes: 1) removal of system error F522:0000, 2) removal of system error F581:0000, 3) change in the alarm threshold for the centrifuge bowl vacuum, and 4) addition of new priming state.
P860019/S167 1/11/01 Real-Time	Boston Scientific Scimed® Quantum Monorail™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for the Boston Scientific Scimed Quantum Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (9, 12, 15, 18, and 20 mm lengths with balloon diameters of 2.5 – 4.0 mm in ¼ mm increments). The quantum Monorail PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Quantum Monorail PTCA Catheter (2.5 – 4.0 mm balloon diameters) is also indicated for the post-delivery expansion of balloon expandable stents.
P860026/S007 1/26/01 Real-Time	Diaphragmatic /Phrenic Nerve Stimulator	Avery Laboratories, Inc. Commack, NY 11725	Approval for changing the method of attaching the battery connector and wiring from the power switches to the printed circuit board, changing the point where the signal is taken to illuminate the battery LED indicator, adding the energy source routing to the front panel of the respiratory rate control circuitry, changing the point where the battery power is obtained for each stimulator output amplifier circuit, and decreasing the sensitivity of the oscillator circuit to transistor output capacitance. The device, as modified, will be marketed under the trade name Mark IV and is indicated for persons who require chronic ventilatory support because of upper motor neuron respiratory muscle paralysis (RMP) or because of central alveolar hypoventilation (CAH) and whose remaining phrenic nerve, lung, and diaphragm function is sufficient to accommodate electrical stimulation.
P890027/S049 1/16/01 180-Day	Nucleus 22 Cochlear Implant System - Children	Cochlear Corporation Englewood, CO 80112	Approval for modification to the firmware, components and labeling of the Portable Programming System (PPS) with no change to the currently approved indications for use.
P910073/S037 1/23/01 Real-Time	Model 6942 Bi-directional Torque Wrench	Guidant/CRM St. Paul, MN 55112	Approval for modifications to the Model 6942 Bi-directional Torque Wrench.
P910077/S036 1/23/01 Real-Time	Model 6942 Bi-directional Torque Wrench	Guidant/CRM St. Paul, MN 55112	Apporoval for modifications to the Model 6942 Bi-directional Torque Wrench.
P930021/S004 1/19/01 Real-Time	EMDOGAIN® Gel	Biora, Inc. Chicago, IL 60610	Approval to change from the EMDOGAIN® two vial system to the EMDOGAIN® Gel filled sterile syringes. The change also includes the addition of the following new manufacturing sites: Statens Serum Institut, Copenhagen, Denmark; Orifice Medical AB, Ystad, Sweden; Paper-Pak Sweden AB, Aneby, Sweden. The device, as modified, will be marketed under the trade name EMDOGAIN® Gel. The device is indicated for use as an adjunct to periodontal surgery as a topical application onto exposed root surfaces to treat intrabony defects not involving furcations due to moderate or severe periodontitis. The device is also indicated for use as an adjunct to a minimally invasive surgical technique in esthetic zones to optimize tissue height for intrabony defects only.
P930035/S009 1/23/01 Real-Time	Model 6942 Bi-directional Torque Wrench	Guidant/CRM St. Paul, MN 55112	Approval for modifications to the Model 6942 Bi-directional Torque Wrench.
P940022/S016 1/12/01 180-Day	Clarion® Multi-Strategy Cochlear Implant Platinum BTE™ Sound Processor	Advanced Bionics Corporation Sylmar, CA 91342	Approval for incorporation of the size-reduced speech processor to be worn behind the ear, known as the platinum BTE™ Sound Processor. The device, as modified, will be marketed under the trade name Clarion® Multi-Strategy Cochlear Implant Platinum BTE™ Sound Processor. The device is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve. Adults: 1) 18 years of age of older 2) Profound, bilateral sensorineural deafness (³ 90 dB) 3) Postlingually deafened 4) Lack of benefit from appropriately fitted hearing aids.
P950015/S008 1/29/01 180-Day	Heart Laser 2 (HL2)	PLC Medical Systems, Inc. Franklin, MA 02038	Approval for a manufacturing change to up-date the laser console portion of the device system from the currently approved HL1 (Heart Laser™) to the HL2 (Heart Laser 2). The device, as modified, will be marketed under the trade name Heart Laser 2 (HL2) , and is indicated for use in the treatment of patients with stable angina (Canadian Cardiovascular Society class 3 or 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium not amenable to direct coronary revascularization.
P960025/S004 1/12/01 Real-Time	Lumbar I/F Cage® System	DePuy AcroMed Raynham, MA 02767	Approval for the use of the Lumbar I/F cage components of the Lumbar I/F Cage® With VSP® Spine System with additional pedicle screw spinal systems. Specifically, for use with the following six additional posterior pedicle screw spinal systems: 1) the Ti alloy version of the VSP Spine System; 2) Ti alloy and stainless steel versions of the ISOLA Spine System; 3) TiMX Spine System; and 4) the Ti alloy and stainless steel versions of the MOSS Miami Spine System. In addition, the device, as modified, will be marketed under the trade name Lumbar I/F Cage System. The indication for these implants has not been changed from that approved on February 2, 1999.
P960040/S019 1/23/01 Real-Time	Model 6942 Bi-directional Torque Wrench	Guidant/CRM St. Paul, MN 55112	Approval for modifications to the Model 6942 Bi-directional Torque Wrench.
P960042/S006 1/17/01 180-Day	Spectranetics Laser Sheath Kits, 12 French, 14 French, and 16 French, Models 500-001, 500-012, and 500-013	Spectranetics Corporation Colorado Springs, CO 80907	Approval for an increase in the laser "on" time to 10 seconds and a decrease in the laser "off" time to 5 seconds. These devices are indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
P960058/S015 1/12/01 180-Day	Clarion® Multi-Strategy Cochlear Implant Platinum BTE™ sound Processor	Advanced Bionics Corporation Sylmar, CA 91342	Approval for incorporation of the size-reduced speech processor to be worn behind the ear, known as the platinum BTE™ Sound Processor. The device, as modified, will be marketed under the trade name Clarion® Multi-Strategy Cochlear Implant Platinum BTE™ Sound Processor. The device is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve. Children: 1) Two years of age through 17 years, if X-rays demonstrate evidence of ossification, children as young as 18 months may be implanted. 2) Profound, bilateral sensorineural deafness (³ 90 dB) 3) Undergone or be willing to undergo a hearing aid trial with appropriately fitted hearing aids. 4) Lack of benefit from appropriately fitted hearing aids. In younger children, lack of benefit with hearing aids is defined as failure to attain basic auditory milestones such as a child’s inconsistent response to his/her name in quiet or to environmental sounds (Meaningful Auditory Integration Scale). In older children, lack of aided benefit is defined as scoring 0% on open-set work recognition (Phonetically Balanced Kindergarten test-Word List) administered with monitored live-voice (70 dB SPL). Both younger and older children should demonstrate only minimal ability on age appropriate open-set sentence measures and a plateau in auditory development.
D970003/S013 1/22/01 Real-Time	DISCOVERY II /INTELIS II Pacemakers and CONSULT Model 2891 Software Application	Guidant/CRM St. Paul, MN 55112	Approval for modifications to the CONSULT Model 2891 Software Application for the DISCOVERY II /INTELIS II Pacemakers, resulting in version 2.4 of the CONSULT programmer software.
D970003/S014 1/22/01 Real-Time	Pulsar Max Models 1170 and 1270	Guidant/CRM St. Paul, MN 55112	Approval for modifications to the Pulsar Max Models 1170 and 1270, specifically the creation of version having headers which are "IS-1 only" compatible.
P970034/S007 1/17/01 180-Day	UV-Absorbing Posterior Chamber Intraocular Lenses	Ophthalmic Innovations International, Inc. Claremont, CA 91711	Approval for a new manufacturing facility located at Ophthalmic Innovations International, Inc., Ontario, California.
P970051/S012 1/16/01 180-Day	Nucleus 24 Cochlear Implant System for Adults and Children	Cochlear Corporation Englewood, CO 80112	Approval for modification to the firmware, components and labeling of the Portable Programming System (PPS) with no change to the currently approved indications for use.
P970058/S009 1/22/01 180-Day	ImageChecker M1000	R2 Technology, Inc. Los Altos, CA 94022	Approval for the addition of a new calcification marker. This marker (a circle) is intended to enable the user of the ImageChecker to differentiate obvious calcifications from more subtle calcifications that appear in analyzed mammograms.
P980001/S023 1/25/01 180-Day	NIROYAL™ Elite Premounted Stent System	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for additional stent lengths (i.e., 9 mm, 12 mm and 18 mm) for the NIROYAL™ Elite Premounted Stent System. The device is 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.
P980022/S006 1/9/01 180-Day	MiniMed Continuous Glucose Monitoring System	MiniMed, Inc. Sylmar, CA 91342	Approval for a new manufacturing site for the manufacturer of the external components of the device. The new site is MiniMed, Inc., Northridge, California.
P980049/S004 1/31/01 Real-Time	Orchestra Programmer	ELA Medical Plymouth, MN 55441	Approval for a "Caution:" label to be placed on the Orchestra Programmer.
P990001/S005 1/8/01 Real-Time	Vitatron Diva Platform	Vitatron, Inc. Minneapolis, MN 55459	Approval for an extension of the shelf life date to 18 months from 12 months and related labeling changes.
P990009/S001 1/22/01 Real-Time	Proceed™ Hemostatic Sealant	Fusion Medical Technologies, Inc. Fremont, CA 94555	Approval for the removal of the neurosurgical exclusion from the "Indications for Use" for Proceed™ Hemostatic Sealant.
P990017/S009 1/19/01 180-Day	ANCURE System	Guidant Corporation Menlo Park, CA 94025	Approval for modifications to the ANCURE System Instructions for Use.
P990030/S001 1/2/01 Real-Time	CoStasis®/ DynaStat™ Surgical Hemostat	Cohesion Technologies Palo Alto, CA 94303	Approval for a change in the method of terminal sterilization from E-Beam to gamma irradiation and requested an additional 3-ml delivery syringe device with the associated labeling change.
P990052/S002 1/3/01 180-Day	Vibrant® D Soundbridge™ System (Audio Processor D Model 404)	Symphonix Devices, Inc. San Jose, CA 95131	Approval for the incorporation of an alternate source supplier’s signal processing circuit into the Audio Processor™ D (Model 404). The device is indicated for adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids.
P990066/S002 1/8/01 180-Day	Senographe 2000D Full Field Digital Mammography System	General Electric Medical Systems Milwaukee, WI 53201	Approval for the Kodak DryView 8610 Printer for use with the Senographe 2000D Full Field Digital Mammography System.

 

Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 31

Summary of PMA Originals Under Review
Total Under Review: 75
Total Active: 34
Total On Hold: 41
Number Greater Than 180 Days: 0

Summary of PMA Supplements Under Review
Total Under Review:235
Total Active: 152
Total On Hold: 83
Number Greater Than 180 Days: 5

Summary of All PMA Submissions Received
Originals: 1
Supplements: 55

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 2
Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 94

FDA Time: 71.7 Days MFR Time: 22.3 Days

Revised 4/1/2002

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