PMA P250024S002
- Device
- Trilogy Transcatheter Heart Valve System
- Applicant
- JenaValve Technology, Inc.
- PMA number
- P250024
- Supplement
- S002
- Product code
- NPT
- Decision date
- 2026-05-18
- Classification
- Cardiovascular
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- approval for the protocol for the Registry-Based Real-World Use Surveillance post-approval study (PAS)
Current openFDA PMA Record#
- Device
- Trilogy Transcatheter Heart Valve System
- Applicant
- JenaValve Technology, Inc.
- PMA number
- P250024
- Supplement
- S002
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-05-18
- Decision code
- APPR
- Date received
- 2026-04-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- approval for the protocol for the Registry-Based Real-World Use Surveillance post-approval study (PAS)