|
Device | TRANSCYTE(TM) |
Generic Name | Dressing, wound and burn, interactive |
Applicant | SHIRE REGENERATIVE MEDICINE 11095 TORREYANA ROAD SAN DIEGO, CA 92121 |
PMA Number | P960007 |
Supplement Number | S014 |
Date Received | 03/01/2000 |
Decision Date | 05/19/2000 |
Conversion Date
|
08/14/2013 |
Product Code |
MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO CONDUCT THE FINAL PRODUCT STERILITY TEST IN-HOUSE UNDER THE CONDITIONS OF AN ISOLATOR ENVIRONMENT. |