PMA P000036S018

Device: DERMAGRAFT (HUMAN FIBROBLAST -DERIVED DERMAL SUBSTITUTE)
Applicant: Shire Regenerative Medicine
PMA number: P000036
Supplement: S018
Product code: MGR
Decision date: 2013-05-21
Generic name: Dressing, wound and burn, interactive
Approval order statement: ADDITION OF A LAMINAR FLOW HOOD, FREEZER REPLACEMENT (SINGLE TO DUAL COMPRESSOR), DISTRIBUTION FREEZER TRANSFER TO WAREHOUSE FOR SAMPLE STORAGE, AND AN ADDITION OF A LIQUID NITROGEN STORAGE FREEZER.

Current openFDA PMA Record#

Device: DERMAGRAFT (HUMAN FIBROBLAST -DERIVED DERMAL SUBSTITUTE)
Applicant: Shire Regenerative Medicine
PMA number: P000036
Supplement: S018
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2013-05-21
Decision code: OK30
Date received: 2013-04-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A LAMINAR FLOW HOOD, FREEZER REPLACEMENT (SINGLE TO DUAL COMPRESSOR), DISTRIBUTION FREEZER TRANSFER TO WAREHOUSE FOR SAMPLE STORAGE, AND AN ADDITION OF A LIQUID NITROGEN STORAGE FREEZER.