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Dermagraft

by Shire Regenerative Medicine

PMA P000036

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P000036↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPCV NumberP000036 Date28 Sep 2001DecidedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0904-03 FDA Unclassified (pre-2012) initiated 2 May 2003

    Did not meet finished device specifications for the DNA criteria.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Dressing, wound and burn, interactive
PMA Number
FDA Product Code
MGR
Device Class
Class III
Advisory Committee
General, Plastic Surgery
FDA Decision
APCV

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Dermagraft is an interactive wound and burn dressing classified as a Dressing, Wound and Burn, Interactive. It is a processed human skin substitute derived from neonatal foreskin fibroblasts and keratinocytes, designed to promote wound healing in full-thickness diabetic foot ulcers.

This device is intended for use in conjunction with standard wound care regimens in patients with adequate blood supply to the affected foot. It is supplied as a sterile, single-use product and requires medical application by a healthcare professional. Authorized under FDA PMA (P000036), Dermagraft is regulated as a Class III medical device.

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