EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,VISIA AF VR,VISIA AF S VR,VISIA AF MRI VR SU
FDA premarket approval P980016/S569 · decided 2016-04-15
Approval details
- PMA number
- P980016
- Supplement
- S569
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,VISIA AF VR,VISIA AF S VR,VISIA AF MRI VR SU
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-02-04
- Decision date
- 2016-04-15
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for minor design and manufacturing changes associated with a component on the hybrid (Telemetry M Module) used in Medtronic ICD and CRT devices.
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