PMA P960007S008

Device: TRANSCYTE
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S008
Product code: MGR
Decision date: 1998-08-14
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Approval for changing the name of the product from Dermagraft-TC to TransCyte(TM) and for minor editoral changes to the Directions for Use and product label. The device, as modified, will be marketed under the trade name TransCyte(TM) and is indicated for use as a temporary wound covering for sugically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement; and for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.

Current openFDA PMA Record#

Device: TRANSCYTE
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S008
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 1998-08-14
Decision code: APPR
Date received: 1998-07-10
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for changing the name of the product from Dermagraft-TC to TransCyte(TM) and for minor editoral changes to the Directions for Use and product label. The device, as modified, will be marketed under the trade name TransCyte(TM) and is indicated for use as a temporary wound covering for sugically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement; and for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.