PMA P190023
- Device
- Navitor Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S011
- Product code
- NPT
- Decision date
- 2026-07-09
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- approval of the revised protocol for the post-approval study (PAS)
Current openFDA PMA Record#
- Device
- Navitor Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S034
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-07-09
- Decision code
- APPR
- Date received
- 2026-06-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- approval of the revised protocol for the post-approval study (PAS)