CareLink SmartSync Cobalt/Crome App, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
FDA premarket approval P010031/S791 · decided 2022-07-20
Approval details
- PMA number
- P010031
- Supplement
- S791
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CareLink SmartSync Cobalt/Crome App, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2022-06-16
- Decision date
- 2022-07-20
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for changes to the Cobalt/Crome devices associated with the Short Circuit Protection.
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