VIRTUOSO II/SECURA/MAXIMO II ICDS
FDA premarket approval P980016/S273 · decided 2011-05-13
Approval details
- PMA number
- P980016
- Supplement
- S273
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIRTUOSO II/SECURA/MAXIMO II ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-01-04
- Decision date
- 2011-05-13
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
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