|
Device | TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE |
Generic Name | Dressing, wound and burn, interactive |
Applicant | SHIRE REGENERATIVE MEDICINE 11095 TORREYANA ROAD SAN DIEGO, CA 92121 |
PMA Number | P960007 |
Supplement Number | S018 |
Date Received | 11/17/2003 |
Decision Date | 12/15/2003 |
Conversion Date
|
08/14/2013 |
Product Code |
MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE ADDITION OF A DIRECT CULTURE-BASED 28-DAY PROCEDURE FOR MYCOPLASMA DETECTION BEFORE TRANCYTE MARKETING RELEASE. |