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Perceval PVS25

by Corcym Inc.

Ref PVS25Model PERCEVAL S SUTURELESS HEART VALVE

Perceval PVS25 is a Class III device made by Corcym Inc., registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-08022057014719), approved under FDA PMA P150011 on 8 Jan 2016 and listed in FDA GUDID since 9 May 2025 (UDI-DI 08022057014719), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

PMA P150011

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08022057014719 Basic UDI-DI 08022057014719UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08022057014719 UDI-DI Date9 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP150011 Date8 Jan 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08022057014719 registered 16 Oct 2026 Active
  • FDA PMA P150011 decided 8 Jan 2016 Active
  • FDA GUDID UDI-DI 08022057014719 listed 9 May 2025 Listed

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.

Timeline

4 dated events

  1. Approved FDA PMA P150011
  2. Recall initiated FDA recalls Z-0716-2017
  3. Listed FDA GUDID 08022057014719
  4. Registered EUDAMED B-08022057014719

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Perceval S Sutureless Heart Valve EUDAMED
Perceval GUDID
Generic name
Aortic open-surgery heart valve bioprosthesis
Model / Ref / Catalog
PVS25, PERCEVAL S SUTURELESS HEART VALVE
Primary DI / UDI-DI
08022057014719
Basic UDI-DI
B-08022057014719
PMA number
FDA product code
LWR
EMDN code
P070301010201 Stented aortic biological valves for surgical implant - non-valve tissue of animal origin
GMDN term
Aortic open-surgery heart valve bioprosthesis
Device class
Class III
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Aortic open-surgery heart valve bioprosthesis

Cleared under the same submission (P150011)

and 8 more cleared under P150011

Similar devices in this category

Other devices filed under BIOLOGICAL CARDIAC VALVES.

Other devices from Corcym Inc.

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    Class II

  • TriMemo TRIM-28

    Class II

  • TriMemo TRIM-30

    Class II

  • TriMemo TRIM-32

    Class II

See all devices from Corcym Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (14, all answered No)