MEDTRONIC GEM ICD
FDA premarket approval P900061/S050 · decided 2001-11-14
Approval details
- PMA number
- P900061
- Supplement
- S050
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC GEM ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-10-26
- Decision date
- 2001-11-14
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE GENERAL USE INDICATION FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS 7227CX, 7227B, 7227D AND 7227E AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
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