Perceval Plus

FDA UDI

Class III (US FDA UDI)

by Corcym Canada Corp

Identity

Trade Name: PERCEVAL PLUS FDA UDI
Generic Name: Aortic open-surgery heart valve bioprosthesis FDA UDI
Model / Reference: PVF-L FDA UDI

Identifiers

Primary DI / UDI-DI: 00896208000818 FDA UDI
PMA Number: P150011 FDA UDI
FDA Product Code: LWR FDA UDI
GMDN Term: Aortic open-surgery heart valve bioprosthesis FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Aortic open-surgery heart valve bioprosthesis

Perceval Plus by Corcym Canada Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aortic open-surgery heart valve bioprosthesis.

MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
Trifecta™ — ST. JUDE MEDICAL, INC. · Class III
CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC · Class III
MOSAIC® — MEDTRONIC, INC. · Class III
CARPENTIER-EDWARDS S.A.VBIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III

Cleared under the same submission

P150011 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Corcym Canada Corp

Sources (1)

FDA UDI 321e89f5-1b57-43be-b67c-5b2192affbbd 33 fields · synced May 31, 2026