CareLink SmartSync Evera MRI Application, CareLink SmartSync Visia AF Application
FDA premarket approval P980016/S830 · decided 2022-10-06
Approval details
- PMA number
- P980016
- Supplement
- S830
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CareLink SmartSync Evera MRI Application, CareLink SmartSync Visia AF Application
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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
- LWS
- 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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