Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Medical Devices

INTEGRA® Dermal Regeneration Template - P900033/S008

Photo of INTEGRA® Dermal Regeneration Template - P900033/S008This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: INTEGRA® Dermal Regeneration Template
Integra LifeSciences Corporation
105 Morgan Lane, Plainsboro, NJ 08536 
Approval Date:
April 19, 2002
Approval Letter:

What is it? INTEGRA® Dermal Regeneration Template is a device to treat the skin of people with severe burns. FDA has recently expanded the approved use of this device. I INTEGRA® may now be used to treat the often disabling scars that result from severe burns.

INTEGRA® has two layers. The bottom layer (dermal) is made of a fibrous protein material (collagen) from cows and a substance made from shark cartilage. The top layer (epidermal) is made of silicone

How does it work? When INTEGRA® is placed on a wound where the burned skin or scarred tissue has been removed, it allows blood vessels and other cells to grow a new layer of skin while the collagen is absorbed into the body. The silicone layer helps close the wound and prevent fluid loss. After approximately 14 to 21 days, the silicone layer is removed, and a very thin graft of the patient's own skin (autograft) is applied to the wound area.

When is it used? INTEGRA® is indicated for use on:

  • Patients with severe burns where there is a limited amount of their own skin to use for autografts or they are too ill to have more wound sites created
  • Patients undergoing reconstructive surgery for burn scars where there is a limited amount of their own skin to use for autografts or they are too ill to have more wound sites created.

What will it accomplish? INTEGRA® will repair damaged skin in burn patients or patients undergoing reconstructive surgery for contractures (scars).

When should it not be used? INTEGRA® should not be used:

  • On patients with known allergies to cow collagen or
  • In patients with clinically diagnosed infected wounds

Additional information: Summary of Safety and Effectiveness and labeling will be available at:

Page Last Updated: 09/05/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English