Evera MRI 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; Visi
FDA premarket approval P980016/S661 · decided 2018-04-10
Approval details
- PMA number
- P980016
- Supplement
- S661
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI 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; Visi
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-03-12
- Decision date
- 2018-04-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Additional universal burn-in load station during battery manufacturing.
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