TransCyte Human Fibroblast-Derived Temporary Skin Substitute
by Shire Regenerative Medicine
PMA P960007
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPCV | NumberP960007 | Date18 Mar 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- 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
The TransCyte Human Fibroblast-Derived Temporary Skin Substitute is a Dressing, wound and burn, interactive (per FDA nomenclature), designed as a temporary biological wound covering. It consists of a silicone membrane seeded with human fibroblasts, providing a living barrier to protect excised full-thickness and deep partial-thickness thermal burn wounds while promoting wound healing prior to autograft placement.
This device is supplied as a sterile, single-use product intended for surgical use in burn care settings. It requires no additional preparation beyond sterile handling and is approved under FDA_PMA (PMA Number: P960007). The dressing is non-magnetic and compatible with MRI environments, though its use must adhere to standard sterile technique protocols. Storage instructions are not specified in the data, but typical practice dictates refrigeration prior to use and adherence to expiration dates.
Other devices from Shire Regenerative Medicine
Questions
AI-generated answers, 18 Sep 2026
What types of burn wounds is this device specifically intended to cover temporarily?
This device, the TransCyte Human Fibroblast-Derived Temporary Skin Substitute, is designed exclusively for surgically excised **full-thickness and deep partial-thickness thermal burn wounds**. It is not intended for superficial burns or non-thermal wounds. The purpose is to act as a living barrier to protect the wound while promoting healing before autograft placement.
Is this product reusable, or is it meant for single-use only?
The TransCyte is a **sterile, single-use** product, intended for surgical use in burn care settings. It requires no additional preparation beyond sterile handling, meaning it is not designed for reuse or reprocessing.
How should this device be stored before use, and what are the key considerations?
While storage instructions are not explicitly detailed in the data, standard practice for this type of biological dressing typically involves **refrigeration** prior to use. It is critical to adhere to the expiration date printed on the packaging to ensure efficacy and sterility.
Can this device be used in an MRI environment, and are there any special precautions?
Yes, the TransCyte is **non-magnetic**, making it compatible with MRI environments. However, its use must still follow **standard sterile technique protocols**, as with any surgical dressing.
What regulatory pathway was followed for this device’s approval, and what does that mean for its use?
This device was approved through the **FDA’s Premarket Approval (PMA) process**, indicated by the PMA number (P960007). This means it underwent rigorous clinical evaluation to demonstrate safety and effectiveness for its intended use as a temporary wound covering in burn patients prior to autograft placement. The approval does not imply suitability for other wound types or non-burn applications.