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Device | MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR |
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 | S004 |
Date Received | 04/13/2001 |
Decision Date | 05/22/2001 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING FOR THE MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR WHICH REFLECTS THE "AF ONLY" INDICATION (I.E., INDICATED FOR USE IN ICD PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS). |
Post-Approval Study | Show Report Schedule and Study Progress |