- Device
- Cobalt XT HF Quad CRT-D MRI SureScan, Coblat HF Quad CRT-D MRI SureScan, Cobalt HF CRT-D MRI SureScan, Crome HF QUad CRT
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S742
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-06-29
- Decision code
- APPR
- Date received
- 2021-03-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to release new firmware RAMware to Cobalt and Crome ICD/CRT-D devices.