MEDTRONIC GEM III AT MODEL 7276 (ICD)
FDA premarket approval P980050/S002 · decided 2001-02-13
Approval details
- PMA number
- P980050
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC GEM III AT MODEL 7276 (ICD)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2000-11-06
- Decision date
- 2001-02-13
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC GEM III AT MODEL 7276 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH THE MODEL 9465 PATIENT ASSISTANT.
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