Amplia, Brava, Claria , Compia, Converto, Maximo, Protecta, Viva
FDA premarket approval P010031/S572 · decided 2017-06-09
Approval details
- PMA number
- P010031
- Supplement
- S572
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Amplia, Brava, Claria , Compia, Converto, Maximo, Protecta, Viva
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-11-16
- Decision date
- 2017-06-09
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for hardware, firmware, labeling, and manufacturing changes to support replacing the Bluetooth (BT) Classic module with a BT Low Energy module in the monitor base station.
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