Amplia MRI/MRI Quad, Brava/Brava Quad, Compia MRI/MRI Quad, Concerto/Concert II, Consulta, Maximo II, Protecta/Protecta
FDA premarket approval P010031/S557 · decided 2016-09-12
Approval details
- PMA number
- P010031
- Supplement
- S557
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Amplia MRI/MRI Quad, Brava/Brava Quad, Compia MRI/MRI Quad, Concerto/Concert II, Consulta, Maximo II, Protecta/Protecta
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-07-13
- Decision date
- 2016-09-12
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for an iOS version of the Carelink Express mobile app.
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