MEDTRONIC MODEL 7273 GEM II DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 9964 (GEM II DR) AP
FDA premarket approval P980016/S002 · decided 1999-01-28
Approval details
- PMA number
- P980016
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 7273 GEM II DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 9964 (GEM II DR) AP
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1998-12-07
- Decision date
- 1999-01-28
- Days to decision
- 52 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Medtronic(R) GEM(TM) II DR Model 7273 Implantable Cardioverter Defibrillator with Medtronic(R) Model 9964 GEM(TM) II DR Programmer Application Software.
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