VIVA XT CRT-D, VIVA S CRT-D, BRAVA CRT-D, VIVA/BRAVA/EVERA SOFTWARE APPLICATION
FDA premarket approval P010031/S318 · decided 2013-01-29
Approval details
- PMA number
- P010031
- Supplement
- S318
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIVA XT CRT-D, VIVA S CRT-D, BRAVA CRT-D, VIVA/BRAVA/EVERA SOFTWARE APPLICATION
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-07-05
- Decision date
- 2013-01-29
- Days to decision
- 208 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE VIVA/BRAVA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION (CRT-D).
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