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Apligraf (Graftskin)

FDA PMA

Class III (US FDA PMA)

PMA P950032

by Organogenesis Inc.

Identity

Trade Name
APLIGRAF (GRAFTSKIN) FDA PMA
Generic Name
Dressing, wound and burn, interactive FDA PMA

Identifiers

PMA Number
P950032 FDA PMA
FDA Product Code
MGR FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APCV FDA PMA

Apligraf is a Dressing, Wound and Burn, Interactive (per FDA nomenclature), consisting of a bilayered living cell-based skin substitute. It combines a dermal layer of human fibroblasts with an epidermal layer of human keratinocytes, designed to promote tissue regeneration in chronic, non-infected wounds. The device is intended for use in partial- and full-thickness skin ulcers caused by venous insufficiency when conventional therapies have failed.

Apligraf is supplied as a sterile, single-use, non-implantable product for topical application to venous leg ulcers of greater than one month duration. It requires standard therapeutic compression and is not intended for use in infected wounds or other indications. The device is regulated under FDA_PMA (PMA Number: P950032) and is classified as a Class III medical device. Storage and handling must comply with manufacturer guidelines to maintain sterility and viability.

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: Product Details | Apligraf®, Organogenesis, Inc. | Apligraf | Skin Substitutes | Wound Care, Organogenesis, Inc. - MassBio, RxAssist - ORGANOGENESIS INC. - Circle of Care Program

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Organogenesis Inc.
FDA Applicant
Organogenesis, Inc.

Sources (1)

  • FDA PMA P950032 24 fields · synced Sep 20, 2026