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Carpentier-Edwards Duraflex Low Pressure Mitral Low Pressure Mitral Bioprosthesis

FDA PMA

Class III (US FDA PMA)

PMA P870077

by Edwards Lifesciences LLC

Identity

Trade Name
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS FDA PMA
Generic Name
replacement Heart-valve FDA PMA

Identifiers

PMA Number
P870077 FDA PMA
FDA Product Code
DYE FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 870.3925 FDA PMA
Regulation Number
870.3925 FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APWD FDA PMA

The Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis is a replacement heart valve intended for use in patients with advanced mitral valvular disease requiring replacement of their natural valve. It is also indicated for patients with a previously implanted mitral valve prosthesis that is no longer functioning adequately and requires replacement.

Supplied as a sterile, single-use implantable device, this bioprosthesis is used in surgical settings for mitral valve replacement. It is regulated as a Class III device under FDA PMA approval (P870077) and is intended for implantation in accordance with surgical standards for cardiovascular prostheses.

Frequently asked questions

What is the Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis used for?

It is used to replace a diseased or malfunctioning mitral valve in patients whose natural mitral valve is too damaged to function properly or who have a previously implanted mitral valve prosthesis that has failed and requires replacement.

Is the Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis reusable?

No, it is supplied as a sterile, single-use implantable device and is not intended for reuse after implantation.

What regulatory pathway was used for the Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis?

The device received approval through the FDA Premarket Approval (PMA) process, as indicated by the PMA number P870077 and the AUTHORIZATIONS field listing FDA_PMA.

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
Edwards Lifesciences LLC
FDA Applicant
Edwards Lifesciences, LLC

Sources (1)

  • FDA PMA P870077 24 fields · synced Oct 6, 2026