PMA P190023S030
- Device
- Navitor Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S030
- Product code
- NPT
- Decision date
- 2026-04-15
- Classification
- Cardiovascular
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- approval for design, supplier, material, and manufacturing process changes to the FlexNav™ Delivery System
Current openFDA PMA Record#
- Device
- Navitor Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S030
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-04-15
- Decision code
- APPR
- Date received
- 2026-01-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for design, supplier, material, and manufacturing process changes to the FlexNav™ Delivery System