Trifecta Valve, Trifecta Valve with Glide Technology
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ST JUDE MEDICAL TRIFECTA VALVE FDA PMA
- Generic Name
- heart-valve, non-allograft tissue FDA PMA
Identifiers
- PMA Number
- P100029 FDA PMA
- FDA Product Code
- LWR FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Trifecta Valve is a Heart-Valve, Non-Allograft Tissue, designed as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve. It is a mechanical heart valve intended for transcatheter or surgical implantation in the aortic position, providing durable hemodynamic performance for patients requiring valve replacement.
This device is supplied sterile and intended for single-use, with regulatory approval under FDA_PMA (PMA Number: P100029). It is classified as a Class III medical device under the Federal Drug Administration. The Trifecta Valve is no longer sold or distributed by the manufacturer as of July 31, 2023, though its original approval and specifications remain documented in regulatory records.
Frequently asked questions
Is the Trifecta Valve still available for purchase or clinical use today?
No, the Trifecta Valve is no longer sold or distributed by Abbott Medical as of July 31, 2023. While its original FDA approval (PMA P100029) and specifications remain documented, it is not actively marketed or supplied for new procedures.
What types of patients was the Trifecta Valve intended for, and how was it implanted?
The Trifecta Valve was designed as a replacement for patients with diseased, damaged, or malfunctioning native or prosthetic aortic heart valves. It was intended for transcatheter (catheter-based) or surgical implantation in the aortic position, providing durable hemodynamic performance for those requiring valve replacement.
How is the Trifecta Valve supplied, and is it reusable?
The Trifecta Valve is supplied sterile and intended for **single-use only**. It was not designed for reuse, adhering to standard practices for Class III medical devices to ensure patient safety and sterility.
What regulatory pathway was followed for the Trifecta Valve’s approval, and what classification does it hold?
The Trifecta Valve received approval via the **FDA’s Premarket Approval (PMA) process**, designated as PMA P100029. It is classified as a **Class III** medical device under FDA regulations, indicating it carries the highest risk level and requires rigorous pre-market approval.
Are there different sizes or models of the Trifecta Valve, and how would a clinician determine the correct fit?
The Trifecta Valve was available in multiple sizes, as indicated by the listed FEI numbers (e.g., 3015287573, 3004478276, etc.), which correspond to specific valve sizes. The correct size would have been determined based on the patient’s anatomical measurements and clinical assessment, typically by a cardiologist or cardiac surgeon during pre-procedure planning.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Copy of Trifecta GT Valve [1.0] [US] [V5] - manuals.eifu.abbott, Abbott Trifecta Valves: Potential Risk of Early Structural Valve ..., Abbott pulls Trifecta heart valves off the market due to early ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100029 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P100029 24 fields · synced Sep 18, 2026