GEM III VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD)
FDA premarket approval P980016/S015 · decided 2000-12-12
Approval details
- PMA number
- P980016
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEM III VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2000-11-01
- Decision date
- 2000-12-12
- Days to decision
- 41 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MEDTRONIC GEM III VR MODEL 7231 ICD AND MEDTRONIC MODEL 9971 (GEM III VR) PROGRAMMER APPLICATION SOFTWARE. THE DEVICE, AS MODIFIED, IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIA.
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