Identity
- Trade Name
- Trifecta™ FDA UDI
- Generic Name
- Aortic open-surgery heart valve bioprosthesis FDA UDI
- Device Name
- Aortic Pericardial Bioprosthetic Heart Valve with Glide Technology FDA UDI
- Model / Reference
- TFGT-27A FDA UDI
- Description
- Aortic Pericardial Bioprosthetic Heart Valve with Glide Technology FDA UDI
Identifiers
- Catalog Number
- TFGT-27A FDA UDI
- Primary DI / UDI-DI
- 05415067018243 FDA UDI
- PMA Number
- P100029 FDA UDI
- FDA Product Code
- LWR FDA UDI
- GMDN Term
- Aortic open-surgery heart valve bioprosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 27 Millimeter FDA UDI
Category: Aortic open-surgery heart valve bioprosthesis
Trifecta™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortic open-surgery heart valve bioprosthesis.
- MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
- MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
- INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC · Class III
- MOSAIC® — MEDTRONIC, INC. · Class III
- CARPENTIER-EDWARDS S.A.VBIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
- CARPENTIER-EDWARDS BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
Cleared under the same submission
P100029 also covers:
- Trifecta™ — ST. JUDE MEDICAL, INC.
- Trifecta™ — ST. JUDE MEDICAL, INC.
- Trifecta™ — ST. JUDE MEDICAL, INC.
- Trifecta™ — ST. JUDE MEDICAL, INC.
- Trifecta™ — ST. JUDE MEDICAL, INC.
- Trifecta™ — ST. JUDE MEDICAL, INC.
- Trifecta™ — ST. JUDE MEDICAL, INC.
- Trifecta™ — ST. JUDE MEDICAL, INC.
- Trifecta™ — ST. JUDE MEDICAL, INC.
- Trifecta™ — ST. JUDE MEDICAL, INC.
- Trifecta™ — ST. JUDE MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI fb2e0912-78df-41d4-b7b6-ff76d581b01b 38 fields · synced Jun 6, 2026