Identity
- Trade Name
- DUROMEDICS BILEAFLET HEART VALVE FDA PMA
- Generic Name
- HEART-VALVE, MECHANICAL FDA PMA
Identifiers
- PMA Number
- P850006 FDA PMA
- FDA Product Code
- LWQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The DuroMedics Bileaflet Heart Valve is a mechanical heart valve designed for aortic and mitral valve replacement. It features a bileaflet design, providing efficient blood flow and durability for long-term cardiac function in patients requiring surgical intervention.
This device is supplied sterile and intended for single-use implantation during open-heart surgery. It is classified as a Class III medical device under FDA regulations, with an approved Premarket Approval (PMA) under PMA number P850006. Compatible with standard surgical techniques, it is regulated under the product code LWQ and requires proper handling and storage as a sterile, implantable device.
Frequently asked questions
What types of heart valve procedures is the DuroMedics Bileaflet Heart Valve intended for, and how is it implanted?
The DuroMedics Bileaflet Heart Valve is designed specifically for aortic and mitral valve replacement during open-heart surgery. It is intended for single-use implantation and requires surgical intervention to place the valve in the appropriate position within the heart. The device is compatible with standard surgical techniques, ensuring proper integration into the patient’s anatomy.
Is the DuroMedics Bileaflet Heart Valve sterile, and how should it be stored before use?
Yes, the DuroMedics Bileaflet Heart Valve is supplied sterile and must be handled as such. Since it is intended for single-use implantation, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, to maintain sterility and integrity until use.
What regulatory pathway does the DuroMedics Bileaflet Heart Valve follow, and what does that mean for its use?
The DuroMedics Bileaflet Heart Valve follows the FDA’s Premarket Approval (PMA) pathway, with an approved PMA number (P850006). This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended surgical use in aortic and mitral valve replacement. Clinicians should confirm compliance with FDA guidelines and proper handling protocols.
Are there different sizes or models of the DuroMedics Bileaflet Heart Valve, and how would I determine the correct size for a patient?
The DuroMedics Bileaflet Heart Valve comes in multiple sizes, as indicated by the registration numbers and FEI numbers listed in the data. The correct size is determined by the surgeon based on the patient’s anatomical measurements and clinical assessment during preoperative planning. Edwards Lifesciences provides sizing guidelines and tools to assist in selecting the appropriate valve for each patient’s specific needs.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P850006 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA PMA P850006 24 fields · synced Sep 18, 2026