- Device
- Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S718
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-11-11
- Decision code
- OK30
- Date received
- 2020-10-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the cathode fabrication manufacturing process for the Cobalt XT, Cobalt, and Crome ICD and CRT-D device family.