Evera MRI DF-1, MRI, S DR, S VR, XT DR, XT VR, Mirro MRI DR, MRI VR, Primo MRI DR, MRI VR, Visia AF MRI DF1, AF MRI VR,
FDA premarket approval P980016/S718 · decided 2019-09-13
Approval details
- PMA number
- P980016
- Supplement
- S718
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI DF-1, MRI, S DR, S VR, XT DR, XT VR, Mirro MRI DR, MRI VR, Primo MRI DR, MRI VR, Visia AF MRI DF1, AF MRI VR,
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-08-26
- Decision date
- 2019-09-13
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Add a second source supplier for the L4 11-Pin Array Ferrule.
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