CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D
FDA premarket approval P010031/S856 · decided 2024-04-26
Approval details
- PMA number
- P010031
- Supplement
- S856
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2024-03-28
- Decision date
- 2024-04-26
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval of new patient enrollment closure for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P010031/S674.
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