GEM MODEL 7227 ICD
FDA premarket approval P900061/S056 · decided 2002-04-16
Approval details
- PMA number
- P900061
- Supplement
- S056
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEM MODEL 7227 ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2002-03-27
- Decision date
- 2002-04-16
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR EXPANSION OF THE FUNCTIONALITY OF THE MODEL 2490A CARELINK MONITOR AND MODEL 2491 SOFTWARE, VERSION 1.0 TO INCLUDE THE GEM, GEM DR, GEM II VR, GEM II DR, GEM III VR AND GEM III DR IMPLANTABLE CARDIOVETER DEFIBRILLATORS.
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