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Bileaflet-Center Opening Cardiac Valve

FDA PMA

Class III (US FDA PMA)

PMA P810002

by Abbott Medical

Identity

Trade Name
BILEAFLET-CENTER OPENING CARDIAC VALVE FDA PMA
Generic Name
HEART-VALVE, MECHANICAL FDA PMA

Identifiers

PMA Number
P810002 FDA PMA
FDA Product Code
LWQ FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA
PMA Supplement
S002 FDA PMA

This device is a mechanical heart valve classified as a bileaflet design, intended for replacement of diseased or dysfunctional heart valves. It features a center-opening mechanism to facilitate blood flow through the aortic or mitral position, ensuring unidirectional valve function to maintain proper cardiac circulation.

The Bileaflet-Center Opening Cardiac Valve is supplied sterile and intended for single-use implantation during surgical procedures. It is regulated under FDA Premarket Approval (PMA) with PMA number P810002 and product code LWQ, adhering to Class III medical device standards. Sizes and configurations are standardized for compatibility with standard surgical techniques and anatomical requirements.

Frequently asked questions

What types of heart valve procedures is this bileaflet valve designed for, and where is it implanted?

This bileaflet valve is specifically designed for surgical replacement of diseased or dysfunctional heart valves in the aortic or mitral positions. Its center-opening mechanism ensures smooth, unidirectional blood flow, making it suitable for maintaining proper cardiac circulation in these critical areas.

Is this valve reusable or intended for single-use, and how is it supplied?

The valve is intended for **single-use only** and is supplied sterile, meaning it is ready for immediate implantation during surgery without requiring additional sterilization. This aligns with standard practices for mechanical heart valves to ensure patient safety and prevent contamination.

What regulatory pathway does this device follow, and what does that mean for its approval status?

This valve follows the **FDA Premarket Approval (PMA) pathway**, which is the highest level of regulatory scrutiny for Class III medical devices. It was granted PMA number **P810002** in 1983, confirming it meets rigorous standards for safety and effectiveness before commercial distribution. The product code **LWQ** further categorizes it under FDA’s classification system.

Are there multiple sizes or configurations available, and how do they relate to surgical techniques?

Yes, the valve comes in **standardized sizes and configurations** tailored to match anatomical requirements and common surgical techniques. This ensures compatibility with typical aortic or mitral valve replacement procedures, allowing surgeons to select the appropriate size for optimal patient outcomes.

How should this valve be stored before use, given its single-use and sterile nature?

Since the valve is **sterile and single-use**, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is designed to maintain sterility until immediate preoperative use, per standard medical device handling protocols.

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

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Abbott Medical

Sources (1)

  • FDA PMA P810002 24 fields · synced Sep 18, 2026