GEM MODEL 7227 CX ICD
FDA premarket approval P900061/S037 · decided 1999-04-15
Approval details
- PMA number
- P900061
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEM MODEL 7227 CX ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-03-31
- Decision date
- 1999-04-15
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval to implement a new test Method and specification for screening the Medtronic(R) Model 7227 Cx GEM(TM) Implantable Defibrillators for premature battery depletion.
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