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Perceval Sutureless Heart Valve

by Corcym S.r.l. Italy PMA

PMA P150011 Product code LWR

Overview

The Perceval Sutureless Heart Valve is a non-allograft tissue heart valve designed for cardiac applications. It is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

This device is manufactured by Corcym S.r.l. and has received FDA PMA authorization under P150011. It is categorized as a Class 3 medical device within the cardiovascular specialty.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP150011 Date8 Jan 2016ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

1 recall · FDA

    • Terminated Z-0716-2017 FDA Class II initiated 31 Oct 2016

    Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.

Specification

PMA · synced 22 Oct 2026

Generic Name
heart-valve, non-allograft tissue
PMA Number
FDA Product Code
LWR
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Other devices from Corcym S.r.l.

See all devices from Corcym S.r.l. →

Questions

  • What is the primary indication for the Perceval Sutureless Heart Valve?

    The device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

  • Who is the manufacturer of this heart valve?

    The Perceval Sutureless Heart Valve is manufactured by Corcym S.r.l., located in Saluggia, Italy.

  • Is this device FDA authorized?

    Yes, the device has received FDA PMA authorization, as indicated by the PMA number P150011.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P150011 24 fields · synced 22 Oct 2026