Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
FDA premarket approval P980016/S809 · decided 2022-03-24
Approval details
- PMA number
- P980016
- Supplement
- S809
- 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
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2022-03-18
- Decision date
- 2022-03-24
- Days to decision
- 6 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Reduce the frequency of the monitoring currently used to control the residual moisture level inside hermetically sealed electronic module assemblies (EMAs).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.