- Device
- Cobalt XT DR MRI SureScan, Cobalt DR MRI SureScan, Crome DR MRI SureScan, Cobalt XT VR MRI SureScan, Cobalt VR MRI SureS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S740
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-05-27
- Decision code
- OK30
- Date received
- 2020-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement previously approved changes for the Cobalt/Chrome device family.