|
Device | DERMAGRAFT (HUMAN FIBROBLAST -DERIVED DERMAL SUBSTITUTE) |
Generic Name | Dressing, wound and burn, interactive |
Applicant | SHIRE REGENERATIVE MEDICINE 11095 TORREYANA ROAD SAN DIEGO, CA 92121 |
PMA Number | P000036 |
Supplement Number | S018 |
Date Received | 04/25/2013 |
Decision Date | 05/21/2013 |
Conversion Date
|
08/14/2013 |
Product Code |
MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |