MEDTRONIC MODEL 7227CX GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA premarket approval P900061/S038 · decided 1999-06-16
Approval details
- PMA number
- P900061
- Supplement
- S038
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 7227CX GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-05-26
- Decision date
- 1999-06-16
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval to revise the circuitry of the high power hybrids used in the Model 7227Cx GEM(TM) and the Model 7273 GEM(TM) II DR implantable cardioverter defibrillators to correct the premature low battery problem.
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