EVERA MRI DF-1 ICD, EVERA MRI IDC, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, VISIA AF MRI DF1 IC
FDA premarket approval P980016/S610 · decided 2017-02-02
Approval details
- PMA number
- P980016
- Supplement
- S610
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERA MRI DF-1 ICD, EVERA MRI IDC, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, VISIA AF MRI DF1 IC
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-11-10
- Decision date
- 2017-02-02
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a minor design change and associated manufacturing changes to the Medtronic Advanced Valve Metal (AVM) Capacitor Feedthrough.
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