PMA P010031S747
- Device
- CareLink SmartSync Cobalt, Crome Application
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Product code
- NIK
- Decision date
- 2021-08-16
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Approval for the CareLink SmartSync MRI Access Application.
Current openFDA PMA Record#
- Device
- CareLink SmartSync Cobalt, Crome Application
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S747
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-08-16
- Decision code
- APPR
- Date received
- 2021-05-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the CareLink SmartSync MRI Access Application.