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Device | JEWEL AF SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980050 |
Supplement Number | S001 |
Date Received | 06/15/2000 |
Decision Date | 04/06/2001 |
Product Code |
LWS |
Docket Number | 01M-0254 |
Notice Date | 06/06/2001 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MEDTRONIC(R) MODEL 7250 JEWEL(R) AF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM, MEDTRONIC MODEL 9465 INCHECK(TM) PATIENTS ASSISTANT AND THE MEDTRONIC TRANSVENE(R) CS/SVC MODEL 6937A LEAD. THE SYSTEM IS INTENDED TO PROVIDE PACING, CARDIOVERSION AND DEFIBRILLATION FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC DRUG REFRACTORY ATRIAL FIBRILLATION AND/OR LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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