|
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 | S013 |
Date Received | 06/29/2012 |
Decision Date | 07/23/2012 |
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 USAGE OF TWO ADDITIONAL VACUUM SEALERS DURING THE PACKAGING PROCESS. |