CareLink SmartSync Visia AF App, CareLink SmartSync Evera MRI App, CareLink SmartSync Viva Consulta Syncra Advisa Ensura
FDA premarket approval P980016/S901 · decided 2024-11-14
Approval details
- PMA number
- P980016
- Supplement
- S901
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CareLink SmartSync Visia AF App, CareLink SmartSync Evera MRI App, CareLink SmartSync Viva Consulta Syncra Advisa Ensura
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2024-09-16
- Decision date
- 2024-11-14
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for software changes to the CareLink SmartSync Device Manager to address instances of inappropriate display of the device electrical reset message, and to correct the functionality of the abort button
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