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PMA Final Decisions Rendered for August 2000

PMA Original Approvals

PMA/PDP SUPPLEMENTAL APPROVALS
APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
N50510/S138 8/11/00 180-Day	Vitek® 2 Streptococcus pneumoniae Susceptibility Test for Vancomycin	BioMerieux, Inc. Hazelwood, MO 63042	Approval for the addition of the antibiotic Vancomycin at concentrations of 0.5 and 1 m g/ml to the Vitek® 2 S. pneumoniae Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 S. pneumoniae Susceptibility Test Cards for use in the Vitek® 2 System and is indicated for use for the susceptibility testing of Streptococcus pneumoniae to Vancomycin in the range of £ 1 to ³ 2 m g/ml.
P790017/S071 8/28/00 180-Day	R1s Rapid Exchange Balloon Dilatation Catheter	Medtronic AVE Inc. Santa Rosa, CA 95403	Approval for the R1s Rapid Exchange Balloon Dilatation Catheter. 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. The R1s Rapid Exchange Balloon Dilatation Catheter is not intended for use as a PTCA Perfusion catheter beyond 60 seconds of balloon inflation.
P860057/S011 8/28/00 Panel Track	Carpentier-Edwards Perimount Pericardial Bioprosthesis Model 6900 Mitral	Edwards Lifesciences, LLC Irvine, CA 92614	Approval for the Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis Model 6900 Mitral, sizes 25, 27, 29, 31, and 33 mm. This device is indicated for patients who require replacement of their native or prosthetic mitral valve.
P880086/S075 8/15/00 Real-Time	Affinity Models DR 5330, SR 5130, DC 5230, Entity DR 5326, and Entity DC 5226 Pulse Generators	St. Jude Medical Sylmar, CA 91392	Approval for removal of the parylene coating from the Affinity Models DR 5330, SR 5130, DC 5230, Entity DR 5326, and Entity DC 5226 Pulse Generators.
P880086/S076 8/25/00 Real-Time	AV Plux DX Model 1368 Steroid-Eluting Single-Pass Lead	St. Jude Medical Sylmar, CA 91392	Approval for an additional lead length of 65 cm.
P910001/S018 8/4/00 180-Day	Vitesse XTO 0.9 mm Coronary Angioplasty Catheter, Model 110-003	Spectranetics Corporation Colorado Springs, CO 80907	Approval for the Vitesse XTO 0.9 mm Coronary Angioplasty Catheter, Model 110-003.
P910066/S015 8/23/00 Real-Time	SpinaLogic Bone Growth Stimulator	OrthoLogic Corporation Tempe, AZ 85281	Approval to 1) Remove the following precaution from the Summary of Safety and Effectiveness and Professional Labeling: "The safety and effectiveness of the SpinaLogic® has only been studied in patients having spinal fusion treatment. The safety and effectiveness of this device in patients receiving instrumentation, which may distort the magnetic field generated by the device and thus produce a less effective treatment, has not been established"; and 2) Modify the following statement In the Risks and Benefits section of the patient labeling from: "The safety and benefit of the SpinaLogic® was not studied for patients who also have metal implants at the spot of their back surgery," to "The SpinaLogic® was not studied for patients who also have metal implants at the spot of their back surgery."
P920031/S001 8/11/00 180-Day	Emit® 2000 Cyclosporine Specific Assay	Syva Company San Jose, CA 95135	Approval for Emit® Cyclosporine Sample Pretreatment Reagent and COBAS INTEGRA 700 Cyclosporine.
P930039/S009 8/31/00 180-Day	Medtronic CAPSURE®FIX NOVUS Model 5076 Steroid Eluting, Bipolar, Screw-in Pacing Lead and Vitatron Crystalline® ActFix Model ICF09 Steroid Eluting, Bipolar Screw-in Pacing Lead	Medtronic, Inc. Minneapolis, MN 55432	Approval for an extendable/retractable screw-in pacing lead. The device, as modified, will be marketed under the trade names Medtronic CAPSURE®FIX NOVUS Model 5076 and Vitatron Crystalline® ActFix Model ICF09 Pacing Leads. These devices are indicated for permanent pacing and sensing of the ventricle and/or atrium when used with a compatible pulse generator.
P950027/S004 8/30/00 180-Days	Hyalgan®	Fidia Pharmaceutical Corporation Washington, DC 200006	Approval to modify labeling, adding the information about the current clinical experience of the device.
P950032/S018 8/31/00 Real-Time	Apligraf (Graftskin)	Organogenesis, Inc. Canton, MA 02021	Approval to introduce new cell strains into the production of Apligraf.
P960036/S001 8/25/00 Real-Time	Memory Lens® Model U940A Ultraviolet-Absorbing Hydrophilic Posterior Chamber IOL	CIBA Vision Corporation Duluth, GA 30097	Approval for a shelf-life extension to 18 month, a proposed protocol for additional shelf-life extensions, and a new dimensional specification.
P960036/S002 8/25/00 180-Day	Memory Lens® UV Absorbing Hydrophilic Posterior Chamber IOL	CIBA Vision Corporation Duluth, GA 30097	Approval for the manufacturing changes that were implemented as a result of the voluntary recall.
P960040/S015 8/4/00 Real-Time	VENTAK® PRIZM™ 1 DR/VR AICD™ System and Model 2844, Version 3.1 Software	Guidant Corporation St. Paul, MN 55112	Approval for the Pulse Generator Models 1860 and 1861, Pulse Generator Software Version 1.3, and Program/Recorder/Monitor Software Model 2844, Version 3.1.
P960040/S016 8/7/00 Real-Time	VENTAK® PRIZM™ DR/VR HE AICD™ System	Guidant Corporation St. Paul, MN 55112	Approval for the High Energy Automatic Implantable Cardioverter Defibrillator (AICD) System, Models 1852, 1853, 1857, and 1858.
P960043/S025 8/3/00 Real-Time	The Closer™ Suture Mediated Closure (SMC) Device	Perclose Redwood, CA 94063	Approval for a manufacturing modification to the foot component of the Closer™ SMC device.
P970010/S004 8/31/00 180-Day	Norian SRS – Skeletal Repair System	Synthes (USA) Paoli, PA 19301	Approval for changing the volume of material used in the post-approval rabbit study.
P970015/S014 8/9/00 180-Day	INTER FIX™ Threaded Fusion Device	Medtronic Sofamor Danek Memphis, TN 38132	Approval for a manufacturing site located at Medtronic Sofamor Danek Manufacturing, Warsaw, Indiana 46582.
P970018/S001 8/29/00 Real-Time	AutoCyte PREP System	TriPath Imaging Redmond, WA 98052	Approval for the protocol for the AutoCyte PREP Post-Approval Study.
P970021/S003 8/14/00 180-Day	ThermaChoice™ Uterine Balloon Therapy System	Gynecare, Inc. Menlo Park, CA 94025	Approval for revised labeling that includes three-year post-treatment information, as required as a condition of approval for the original PMA application.
P970034/S006 8/31/00 180-Day	Posterior Chamber PMMA Intraocular Lenses (IOLs)	Ophthalmic Innovations International, Inc. Claremont, CA 91711	Approval to extend the power range for the lenses to include powers between +3.5 and –12.0 diopters (excluding zero diopter) in 0.5 diopter increments.
P970043/S009 8/28/00 180-Day	LADAR Vision® Excimer Laser System	Summit Autonomous Corporation Orlando, FL 32826	Approval for reducing by 20% the ablation depth values that are provided in the Physician Booklet and displayed by the device.
P970051/S010 8/21/00 180-Day	Nucleus 24 Cochlear Implant System for Adults and Children – Design Modification – CI 24R(ST) Straight Electrode with 24K Stimulator Receiver	Cochlear Corporation Englewood, CO 80112	Approval for a design modification, including the straight electrode of the CI 24 M with the 24 K downsized stimulator receiver. The device, as modified, will be marketed under the trade name CI 24R(ST), and is indicated for children age 18 month through 17 years of age who have bilateral profound sensorineural deafness and demonstrate little or no benefit from appropriate binaural hearing aids, and for adults, age 18 years and older who have bilateral moderate to profound sensorineural hearing loss and obtain limited benefit from appropriate hearing aids.
P970061/S009 8/22/00 180-Day	Boston Scientific/Scimed Radius™ Coronary Stents	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for an additional manufacturing facility located at Boston Scientific Scimed, Inc., Plymouth, Minnesota 55442 and an additional sterilization facility located at IBA, Willowbrook, Illinois 60521.
P980001/S017 8/3/00 180-Day	NIROYAL™ Elite Premounted Stent System	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for the NIROYAL™ Elite Premounted Stent Systems. 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) with a 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.
P980008/S003 8/15/00 Real-Time	LaserScan LSX Excimer Laser System	LaserSight Technologies, Inc. Winter Park, FL 32792	Approval for a change in the laser pulse repetition rate from 100 to 200 Hz.
P980022/S001 8/9/00 180-Day	MiniMed Continuous Glucose Monitoring System	MiniMed, Inc. Sylmar, CA 91342	Approval for the postapproval study protocols.

 

Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 27

Summary of PMA Originals Under Review
Total Under Review: 82
Total Active: 37
Total On Hold: 45
Number Greater Than 180 Days: 1

Summary of PMA Supplements Under Review
Total Under Review: 200
Total Active: 106
Total On Hold: 94
Number Greater Than 180 Days: 5

Summary of All PMA Submissions Received
Originals: 2
Supplements: 56

Summary of PMA Supplement Approval/Denial Decision Times
Number of Approvals: 27
Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 152.7
FDA Time: 126.2 Days
MFR Time: 26.5 Days