MODEL 7271 GEM DR ICD
FDA premarket approval P980016/S007 · decided 1999-08-12
Approval details
- PMA number
- P980016
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 7271 GEM DR ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-07-07
- Decision date
- 1999-08-12
- Days to decision
- 36 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for modifications to the high power circuitry of the Medtronic(R) Model 7271 GEM(R) DR Implantable Cardioverter Defibrillator.
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