CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application
FDA premarket approval P010031/S737 · decided 2021-05-27
Approval details
- PMA number
- P010031
- Supplement
- S737
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2021-03-01
- Decision date
- 2021-05-27
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for new cardiovascular implantable electronic device (CIED) software applications on the CareLink SmartSync Device Manager.
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