EveraMRIDF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S YR ICD, Evera XT YR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Vi
FDA premarket approval P980016/S871 · decided 2023-12-07
Approval details
- PMA number
- P980016
- Supplement
- S871
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EveraMRIDF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S YR ICD, Evera XT YR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Vi
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2023-11-07
- Decision date
- 2023-12-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for updates to the H3 battery cathode mix chorine manufacturing specification and test method
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