SECURA DR/VR, VIRTUOSO II DR/VR, MAXIMO II DR/VR ICDS
FDA premarket approval P980016/S187 · decided 2011-04-04
Approval details
- PMA number
- P980016
- Supplement
- S187
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECURA DR/VR, VIRTUOSO II DR/VR, MAXIMO II DR/VR ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-03-06
- Decision date
- 2011-04-04
- Days to decision
- 759 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADVISA DR A4DR01 IMPLANTABLE PULSE GENERATOR, MODEL 9995 APPLICATION SOFTWARE V7.3, CARELINK MONITOR MODEL 2490G UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE.
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