MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR
FDA premarket approval P980050/S004 · decided 2001-05-22
Approval details
- PMA number
- P980050
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2001-04-13
- Decision date
- 2001-05-22
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- 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).
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