Evera NRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot
FDA premarket approval P980016/S667 · decided 2018-05-03
Approval details
- PMA number
- P980016
- Supplement
- S667
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera NRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-04-12
- Decision date
- 2018-05-03
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Modify the hybrid burn-in manufacturing process step.
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