BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-D
FDA premarket approval P010031/S398 · decided 2013-10-29
Approval details
- PMA number
- P010031
- Supplement
- S398
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-09-04
- Decision date
- 2013-10-29
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MINOR DESIGN CHANGE IN THE MULTILAYER CERAMIC CAPACITORS MADE BY A SECOND TIER SUPPLIER WHICH ARE USED IN THE DEVICES.
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