GEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC, INTRINSIC 30 IMPLANTABLE DEVICES
FDA premarket approval P980016/S068 · decided 2006-02-28
Approval details
- PMA number
- P980016
- Supplement
- S068
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC, INTRINSIC 30 IMPLANTABLE DEVICES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-02-01
- Decision date
- 2006-02-28
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ELECTRICAL SAFETY INSTRUCTIONS FOR THE CARELINK MONITOR.
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