CareLink SmartSync Visia AF Application Software, CareLink SmartSync Evera MRI Application Software, Cobalt MRI ICD, Cob
FDA premarket approval P980016/S863 · decided 2023-09-22
Approval details
- PMA number
- P980016
- Supplement
- S863
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CareLink SmartSync Visia AF Application Software, CareLink SmartSync Evera MRI Application Software, Cobalt MRI ICD, Cob
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2023-07-03
- Decision date
- 2023-09-22
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for labeling changes, software changes to the CareLink SmartSync system, and firmware changes to the Blackwell family of devices to address SCP1 and L404 reset events
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