Brava, Brava Quad, Concerto II, Consulta, Maximo II, Protecta, Protecta XT, Viva Quad C, Viva Quad S, Viva Quad XT, Viva
FDA premarket approval P010031/S809 · decided 2023-02-08
Approval details
- PMA number
- P010031
- Supplement
- S809
- 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 C, Viva Quad S, Viva Quad XT, Viva
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2022-11-17
- Decision date
- 2023-02-08
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the Alert Management Feature/System for the CareLink network.
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