Visia AF software SW035 Version 8.1
FDA premarket approval P980016/S615 · decided 2017-02-14
Approval details
- PMA number
- P980016
- Supplement
- S615
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Visia AF software SW035 Version 8.1
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-12-05
- Decision date
- 2017-02-14
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for software updates to address negative artifacts.
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