PMA P000036S008

Device: DERMAGRAFT
Applicant: Shire Regenerative Medicine
PMA number: P000036
Supplement: S008
Product code: MGR
Decision date: 2012-04-18
Generic name: Dressing, wound and burn, interactive
Approval order statement: APPROVAL FOR MANUFACTURING SITES LOCATED AT FLEXMEDICAL, IN TIJUANA, BAJA CALIFORNIA, MEXICO AND ADVANCED BIOHEALING INC., IN SAN DIEGO, CALIFORNIA.

Current openFDA PMA Record#

Device: DERMAGRAFT
Applicant: Shire Regenerative Medicine
PMA number: P000036
Supplement: S008
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2012-04-18
Decision code: APPR
Date received: 2012-03-13
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR MANUFACTURING SITES LOCATED AT FLEXMEDICAL, IN TIJUANA, BAJA CALIFORNIA, MEXICO AND ADVANCED BIOHEALING INC., IN SAN DIEGO, CALIFORNIA.