CONCERTO, VIRTUOSO (MODEL SW002 V8.0)
FDA premarket approval P980016/S366 · decided 2013-03-13
Approval details
- PMA number
- P980016
- Supplement
- S366
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO, VIRTUOSO (MODEL SW002 V8.0)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-07-17
- Decision date
- 2013-03-13
- Days to decision
- 239 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE VIRTUOSO II, MAXIMO II, SECURA DF4, SECURA, ENTRUST AND VIRTUOSO.
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