MODEL 7271 GEM DR ICD
FDA premarket approval P980016/S010 · decided 1999-12-23
Approval details
- PMA number
- P980016
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 7271 GEM DR ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-10-21
- Decision date
- 1999-12-23
- Days to decision
- 63 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for low power hybrid circuitry changes which will improve the patient alert drive transistors, the charge pump circuit and the manufacturing process.
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