Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD, Mirro MRI DR/VR ICD
FDA premarket approval P980016/S838 · decided 2022-10-20
Approval details
- PMA number
- P980016
- Supplement
- S838
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD, Mirro MRI DR/VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2022-10-18
- Decision date
- 2022-10-20
- Days to decision
- 2 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Add a second supplier for a component used in connector subassemblies at MECC.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.