Navitor Transcatheter Aortic Valve Implantation System
FDA premarket approval P190023/S025 · decided 2025-05-07
Approval details
- PMA number
- P190023
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Navitor Transcatheter Aortic Valve Implantation System
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-01-31
- Decision date
- 2025-05-07
- Days to decision
- 96 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- approval for a leaflet design change for the 23 mm and 25 mm Navitor Vision Valves, and an alternate inner and outer fabric cuff component supplier for all sizes (23 mm, 25 mm, 27 mm, 29 mm) of the Navitor Vision Valves
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