BRAVA CRT-D,VIVA S CRT-D, VIVA XT CRT-D
FDA premarket approval P010031/S435 · decided 2014-05-13
Approval details
- PMA number
- P010031
- Supplement
- S435
- 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
- 2014-03-19
- Decision date
- 2014-05-13
- 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 REPLACEMENT TELEMETRY M COMPONENT ANDASSOCIATED MANUFACTURING CHANGES.
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