- Device
- Navitor Transcatheter Aortic Valve Implantation System; Navitor Transcatheter Aortic Heart Valve; FlexNav Delivery Syste
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S002
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2023-01-13
- Decision code
- APPR
- Date received
- 2021-10-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes including modification of the valve inner skirt material, addition of an outer skirt, and minor changes to the valve stent frame and loading system