PMA P980016S954
- Device
- Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S954
- Product code
- LWS
- Decision date
- 2026-03-27
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
Current openFDA PMA Record#
- Device
- Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S954
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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