- Device
- Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql, DTPA2QQ); Crome M
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S933
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2026-10-05
- Decision code
- OK30
- Date received
- 2026-09-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to qualify new manufacturing equipment