MEDTRONIC(R) MODEL 7227CX GEM (TM) IMPLANTABLE CARDIOVERTER
FDA premarket approval P900061/S035 · decided 1998-10-05
Approval details
- PMA number
- P900061
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC(R) MODEL 7227CX GEM (TM) IMPLANTABLE CARDIOVERTER
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1998-02-17
- Decision date
- 1998-10-05
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Medtronic(R) Model 7227Cx GEM(TM) Implantabel Cardioverter Defibrillator with Model 9962 Software and the Model 9466 Patient Magnet.
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