PMA P960007S005

Device: DERMAGRAFT-TC(TM)
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S005
Product code: MGR
Decision date: 1998-02-12
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Approval for a change in manufacturing to automate the cell expansion process used to prepare the fibroblast cells for inoculation into the Dermagraft-TC growth system.

Current openFDA PMA Record#

Device: DERMAGRAFT-TC(TM)
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S005
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 1998-02-12
Decision code: APPR
Date received: 1997-10-29
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in manufacturing to automate the cell expansion process used to prepare the fibroblast cells for inoculation into the Dermagraft-TC growth system.