Evera MRI DF-1, Evera S DR/VR, Evera XT DR/VR, Mirro MRI DR/VR, Primo MRI DR/VR, Protecta VR/XT, Secura DR, Visia AF MRI
FDA premarket approval P980016/S716 · decided 2019-08-06
Approval details
- PMA number
- P980016
- Supplement
- S716
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI DF-1, Evera S DR/VR, Evera XT DR/VR, Mirro MRI DR/VR, Primo MRI DR/VR, Protecta VR/XT, Secura DR, Visia AF MRI
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-07-12
- Decision date
- 2019-08-06
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Implementation of process controls for Soft Straight-Line Finish (SLF) cosmetic work.
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