BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO 11 CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, PROTECTA XT CRT-D,
FDA premarket approval P010031/S477 · decided 2015-01-30
Approval details
- PMA number
- P010031
- Supplement
- S477
- Supplement type
- Real-Time Process
- Trade name
- BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO 11 CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, PROTECTA XT CRT-D,
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-12-18
- Decision date
- 2015-01-30
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MINOR DESIGN TOLERANCE CHANGE AND ASSOCIATEDINSPECTION PROCEDURE CHANGES FOR MULTIPOLAR FEEDTHROUGH INSULATORS FOR SELECTED IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS.
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