PMA P960007S009

Device: TRANSCYTE (DERMAGRAFT-TC)
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S009
Product code: MGR
Decision date: 1998-12-01
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Approval that the ATP assay be used in place of the MTT assay as a means of monitoring and predicting product characteristics. The product release criteria of the ATP assay stipulate that production lots of TransCyte will be harvested between incubation days 12 to 16 and must have an ATP value in the range of 0.083 to 0.127 moles per bioreactor to be considered an acceptable lot.

Current openFDA PMA Record#

Device: TRANSCYTE (DERMAGRAFT-TC)
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S009
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 1998-12-01
Decision code: APPR
Date received: 1998-07-24
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval that the ATP assay be used in place of the MTT assay as a means of monitoring and predicting product characteristics. The product release criteria of the ATP assay stipulate that production lots of TransCyte will be harvested between incubation days 12 to 16 and must have an ATP value in the range of 0.083 to 0.127 moles per bioreactor to be considered an acceptable lot.