MEDTRONIC JEWEL CARDIOVERTER DEFIBRILLATOR
FDA premarket approval P900061/S023 · decided 1996-09-25
Approval details
- PMA number
- P900061
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC JEWEL CARDIOVERTER DEFIBRILLATOR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1996-04-03
- Decision date
- 1996-09-25
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODEL 9895E APPLICATION SOFTWARE, VERSION T6E6V3, FOR MODEL 9790 AND 9790C PROGRAMMERS WHICH PROGRAM THE MODELS 7616/7217, 7201, 7219/02 AND 7220 IMPLANTABLE ARRHYTHMIA MANAGEMENT DEVICES
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