CareLink SmartSync Cobalt, Crome App
FDA premarket approval P010031/S750 · decided 2021-09-29
Approval details
- PMA number
- P010031
- Supplement
- S750
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CareLink SmartSync Cobalt, Crome App
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2021-07-01
- Decision date
- 2021-09-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval to release updates to the CareLink SmartSync Cobalt, Crome App.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.