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ProCol Vascular Bioprosthesis

FDA PMA

Class III (US FDA PMA)

PMA P020049

by LeMaitre Vascular, Inc.

Identity

Trade Name
PROCOL VASCULAR BIOPROSTHESIS FDA PMA
Generic Name
Tissue graft of 6mm and greater FDA PMA

Identifiers

PMA Number
P020049 FDA PMA
FDA Product Code
LXA FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APWD FDA PMA

The ProCol Vascular Bioprosthesis is a tissue graft of 6mm and greater indicated for the creation of a bridge graft for vascular access subsequent to at least one previously failed prosthetic access graft. It is classified as a Class III device under product code LXA.

Supplied by LeMaitre Vascular, Inc., the device received FDA PMA approval (P020049) on July 29, 2003, following a decision date of APWD. It is authorized for use in vascular access procedures as specified in the approval documentation.

Frequently asked questions

What is the ProCol Vascular Bioprosthesis indicated for?

The ProCol Vascular Bioprosthesis is indicated for the creation of a bridge graft for vascular access subsequent to at least one previously failed prosthetic access graft, as stated in the approval documentation from the FDA PMA.

What regulatory authorization does the ProCol Vascular Bioprosthesis have?

The ProCol Vascular Bioprosthesis has FDA PMA approval under number P020049, with a decision date of July 29, 2003, and decision code APWD, as recorded in the device data.

Who manufactures the ProCol Vascular Bioprosthesis and where are they located?

The ProCol Vascular Bioprosthesis is manufactured by LeMaitre Vascular, Inc., located at 63 Second Ave., Burlington, MA 01803, as specified in the manufacturer and address fields of the device data.

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: LeMaitre Vascular Acquires ProCol® Vascular Bioprosthesis, [PDF] ProCol® Vascular Bioprosthesis - LeMaitre, ProCol Vascular Bioprosthesis | LeMaitre, LeMaitre Vascular Acquires ProCol Vascular Bioprosthesis, MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
LeMaitre Vascular, Inc.

Sources (1)

  • FDA PMA P020049 24 fields · synced Sep 18, 2026