PMA P190023S031
- Device
- Navitor Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S031
- Product code
- NPT
- Decision date
- 2026-03-17
- Classification
- Cardiovascular
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- reduced frequency of bioburden and endotoxin sampling for all implantation system components
Current openFDA PMA Record#
- Device
- Navitor Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S031
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-03-17
- Decision code
- OK30
- Date received
- 2026-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reduced frequency of bioburden and endotoxin sampling for all implantation system components