MAXIMO II DR,MAXIMO II VR,VIRTUOSO II VR,SECURA DR,SECURA VR
FDA premarket approval P980016/S452 · decided 2014-07-09
Approval details
- PMA number
- P980016
- Supplement
- S452
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAXIMO II DR,MAXIMO II VR,VIRTUOSO II VR,SECURA DR,SECURA VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-12-18
- Decision date
- 2014-07-09
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC VIVA CRT-P MODEL C6TR01 IMPLANTABLEPACEMAKER WITH CARDIAC RESYNCHRONIZATION; PROGRAMMER SOFTWARE APPLICATION MODEL 9995 V8.3; AND UPDATES TO THE MEDTRONIC CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL2020A AND CARELINK EXPRESS MODEL 2020B FIRMWARE, AND TO THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA).
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