Trifecta™ TF-21A
Trifecta™ TF-21A is a Class III device made by St. Jude Medical, Inc., approved under FDA PMA P100029 on 20 Apr 2011 and listed in FDA GUDID since 23 Sep 2014 (UDI-DI 05414734052023), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05414734052023 | Date23 Sep 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP100029 | Date20 Apr 2011 | StatusActive |
Official records
- AccessGUDID record 05414734052023
- FDA PMA database P100029
Across registries
- FDA PMA P100029 decided 20 Apr 2011 Active
- FDA GUDID UDI-DI 05414734052023 listed 23 Sep 2014 Listed
Timeline
- Approved FDA PMA P100029
- Listed FDA GUDID 05414734052023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Trifecta™
- Generic name
- Aortic open-surgery heart valve bioprosthesis
- Model / Ref / Catalog
- TF-21A
- Primary DI / UDI-DI
- 05414734052023
- PMA number
- FDA product code
- LWR
- GMDN term
- Aortic open-surgery heart valve bioprosthesis
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Outer Diameter — 21 Millimeter
Similar devices in this category
Other devices filed under Aortic open-surgery heart valve bioprosthesis.