CareLink SmartSync Viva Brava Evera Application, CareLink SmartSync Claria Amplia Compia Application
FDA premarket approval P010031/S796 · decided 2022-10-06
Approval details
- PMA number
- P010031
- Supplement
- S796
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CareLink SmartSync Viva Brava Evera Application, CareLink SmartSync Claria Amplia Compia Application
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2022-07-25
- Decision date
- 2022-10-06
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for new SmartSync software applications to provide support for additional families of market-released CIEDs.
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