MEDTRONIC GEMIII DR MODEL 7275 (ICD), MODEL 9970 PROGRAMMER APPLICATION SOFTWARE
FDA premarket approval P980016/S014 · decided 2000-11-29
Approval details
- PMA number
- P980016
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC GEMIII DR MODEL 7275 (ICD), MODEL 9970 PROGRAMMER APPLICATION SOFTWARE
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2000-09-11
- Decision date
- 2000-11-29
- Days to decision
- 79 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MEDTRONIC GEM III DR MODEL 7275 ICD AND MEDTRONIC MODEL 9970 (GEM III DR) 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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