PMA P960007S021

Device: TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S021
Product code: MGR
Decision date: 2011-09-20
Generic name: Dressing, wound and burn, interactive
Approval order statement: APPROVAL FOR CHANGING FROM THE USE OF FETAL BOVINE SERUM TO THE USE OF BOVINE CALF SERUM AS A MEDIA SUPPLEMENT FOR EXPANDING CELLS IN EXPANDED SURFACE ROLLER BOTTLES, I.E., THE CELL EXPANSION PROCESS.

Current openFDA PMA Record#

Device: TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S021
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2011-09-20
Decision code: APPR
Date received: 2011-03-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGING FROM THE USE OF FETAL BOVINE SERUM TO THE USE OF BOVINE CALF SERUM AS A MEDIA SUPPLEMENT FOR EXPANDING CELLS IN EXPANDED SURFACE ROLLER BOTTLES, I.E., THE CELL EXPANSION PROCESS.