PMA P190023
- Device
- Navitor Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S011
- Product code
- NPT
- Decision date
- 2026-05-26
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- a manufacturing process enhancement to the application of pouch and tray labels
Current openFDA PMA Record#
- Device
- Navitor Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S032
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-05-26
- Decision code
- OK30
- Date received
- 2026-04-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing process enhancement to the application of pouch and tray labels