BRAVA;BRAVA QUAD; CONCERTO II;CONSULTA;MAXIMO II;PROTECTA;PROTECTA XT;VIVA QUAD S;VIVA QUAD XT;VIVA S;VIVA XT CRT-DS
FDA premarket approval P010031/S526 · decided 2016-03-10
Approval details
- PMA number
- P010031
- Supplement
- S526
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRAVA;BRAVA QUAD; CONCERTO II;CONSULTA;MAXIMO II;PROTECTA;PROTECTA XT;VIVA QUAD S;VIVA QUAD XT;VIVA S;VIVA XT CRT-DS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-01-11
- Decision date
- 2016-03-10
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the addition of a passivation layer to the XD429 MOSFET used in the hybrid charging circuit and changes in the manufacturing process of the XD429
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