VISIA AF VR, VISIA AF MRI VR SURESCAN, EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, P
FDA premarket approval P980016/S585 · decided 2016-04-26
Approval details
- PMA number
- P980016
- Supplement
- S585
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISIA AF VR, VISIA AF MRI VR SURESCAN, EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, P
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-04-14
- Decision date
- 2016-04-26
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for minor software updates to the Instrument Command Library (ICL) Model 2691 to provide support for the Visia AF family of devices.
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