MARQUIS DR/VR MODELS 7274, 7230B, 7230CX, 7230E
FDA premarket approval P980016/S075 · decided 2006-07-26
Approval details
- PMA number
- P980016
- Supplement
- S075
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MARQUIS DR/VR MODELS 7274, 7230B, 7230CX, 7230E
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-06-02
- Decision date
- 2006-07-26
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MODIFICATION TO THE HIGH VOLTAGE CAPACITOR LINER USER IN THE REFERENCED DEFIBRILLATORS.
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