GEM II IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR MODELS 7273 & 7229
FDA premarket approval P980016/S012 · decided 1999-12-13
Approval details
- PMA number
- P980016
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEM II IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR MODELS 7273 & 7229
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-11-08
- Decision date
- 1999-12-13
- Days to decision
- 35 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for modifications to the circuitry of the Medtronic(R) Models 7273 and 7229 Implantable Cardioverter Defibrillators.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.