|
Device | TRANSCYTE |
Generic Name | Dressing, wound and burn, interactive |
Applicant | SHIRE REGENERATIVE MEDICINE 11095 TORREYANA ROAD SAN DIEGO, CA 92121 |
PMA Number | P960007 |
Supplement Number | S013 |
Date Received | 09/02/1999 |
Decision Date | 03/16/2000 |
Conversion Date
|
08/14/2013 |
Product Code |
MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to extend the expiration date to 20 months and to revise product labeling to indicate that the device may be stored by the end user at temperatures between -70C and -20C. |