PMA P250024
- Device
- Trilogy Transcatheter Heart Valve System
- Applicant
- JenaValve Technology, Inc.
- PMA number
- P250024
- Supplement
- S003
- Product code
- NPT
- Decision date
- 2026-07-09
- Classification
- Cardiovascular
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- a modification to the receiving inspection sampling plan for delivery system components
Current openFDA PMA Record#
- Device
- Trilogy Transcatheter Heart Valve System
- Applicant
- JenaValve Technology, Inc.
- PMA number
- P250024
- Supplement
- S003
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-07-09
- Decision code
- OK30
- Date received
- 2026-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a modification to the receiving inspection sampling plan for delivery system components