PMA P980016
- Device
- Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S847
- Product code
- LWS
- Decision date
- 2026-10-29
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- to adjust rise time measurement upper limit during final functional electrical testing
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
- S967
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-10-29
- Decision code
- OK30
- Date received
- 2026-10-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to adjust rise time measurement upper limit during final functional electrical testing