Cobalt MRI ICD DDPB3D4, DVPB3D4; Cobalt XT MRI ICD DDPA2D4, DVPA2D4; Crome MRI ICD DDPC3D4, DVPC3D4; Evera MRI DF-1 ICD
FDA premarket approval P980016/S942 · decided 2025-12-15
Approval details
- PMA number
- P980016
- Supplement
- S942
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cobalt MRI ICD DDPB3D4, DVPB3D4; Cobalt XT MRI ICD DDPA2D4, DVPA2D4; Crome MRI ICD DDPC3D4, DVPC3D4; Evera MRI DF-1 ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2025-11-13
- Decision date
- 2025-12-15
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- updates to the incoming inspection procedure for interconnect ribbon components
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