BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT C
FDA premarket approval P010031/S546 · decided 2016-04-26
Approval details
- PMA number
- P010031
- Supplement
- S546
- 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 C
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-04-14
- Decision date
- 2016-04-26
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for minor software updates to the Instrument Command Library (ICL) Model 2691 to provide support for the Visia AF family of devices.
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