PMA P010031S921
- Device
- Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S921
- Product code
- NIK
- Decision date
- 2026-03-27
- Classification
- Cardiovascular
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Current openFDA PMA Record#
- Device
- Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S921
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2026-03-27
- Decision code
- OK30
- Date received
- 2026-03-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier