PMA P960007S015

Device: TRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S015
Product code: MGR
Decision date: 2001-08-30
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: APPROVAL FOR AMENDED LABELING TO INCLUDE INFORMATION REGARDING THE RESULTS OF TESTING THE DONOR MOTHER'S SERA FOR VIRUSES AND OTHER INFECTIOUS AGENTS.

Current openFDA PMA Record#

Device: TRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S015
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2001-08-30
Decision code: APPR
Date received: 2001-06-26
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR AMENDED LABELING TO INCLUDE INFORMATION REGARDING THE RESULTS OF TESTING THE DONOR MOTHER'S SERA FOR VIRUSES AND OTHER INFECTIOUS AGENTS.