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Carpentier-Edwards S.A.V. Porcine Bioprosthesis Model 2650 (Aortic)

FDA PMA

Class III (US FDA PMA)

PMA P010041

by Edwards Lifesciences LLC

Identity

Trade Name
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC) FDA PMA
Generic Name
replacement Heart-valve FDA PMA

Identifiers

PMA Number
P010041 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 S.A.V. Porcine Bioprosthesis Model 2650 (Aortic) is a supra-annular aortic heart valve replacement designed for patients requiring native or prosthetic aortic valve substitution. This device falls under the classification of a replacement heart-valve, featuring a porcine bioprosthesis constructed from treated porcine tissue.

Intended for surgical implantation, the Model 2650 is available in sizes 21mm, 23mm, 25mm, and 27mm. It is classified as a Class III device under FDA regulations and holds a Premarket Approval (PMA) designation (PMA P010041). The device is non-sterile prior to surgical preparation and must be sterilized by the surgeon prior to use.

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 Carpentier-Edwards Bioprosthesis, PDF Carpentier-Edwards PERIMOUNT, Carpentier Edwards Bioprosthesis - an overview - ScienceDirect

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 P010041 24 fields · synced Sep 18, 2026