PMA P250024S005
- Device
- Trilogy Transcatheter Heart Valve System
- Applicant
- JenaValve Technology, Inc.
- PMA number
- P250024
- Supplement
- S005
- Product code
- NPT
- Decision date
- 2026-10-13
- Classification
- Cardiovascular
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- an additional abattoir for sourcing pericardium tissue
Current openFDA PMA Record#
- Device
- Trilogy Transcatheter Heart Valve System
- Applicant
- JenaValve Technology, Inc.
- PMA number
- P250024
- Supplement
- S005
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-10-13
- Decision code
- OK30
- Date received
- 2026-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional abattoir for sourcing pericardium tissue