Perceval S ICV1242

Perceval S ICV1242 is a Class III device made by Corcym Inc., approved under FDA PMA P150011 on 8 Jan 2016 and listed in FDA GUDID since 15 Jun 2016 (UDI-DI 08022057014856), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 closed

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08022057014856 UDI-DI	Date15 Jun 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA PMAAPPR from GUDID Approved	NumberP150011	Date8 Jan 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08022057014856
FDA PMA database PMA number P150011

Across registries

2 registries list this device

FDA PMA P150011 decided 8 Jan 2016 Active
FDA GUDID UDI-DI 08022057014856 listed 15 Jun 2016 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

3 dated events

8 Jan 2016 Approved FDA PMA P150011
15 Jun 2016 Listed FDA GUDID 08022057014856
31 Oct 2016 Recall initiated FDA recalls Z-0716-2017

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name: Perceval S
Generic name: Heart valve prosthesis holder, single-use
Model / reference: ICV1242

Primary DI / UDI-DI: 08022057014856
FDA product code: LWR
GMDN term: Heart valve prosthesis holder, single-use

Device class: Class III
GUDID distribution status: In Commercial Distribution

Other devices from Corcym Inc.

TriMemo TRIM-26

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
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)