|
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 | S017 |
Date Received | 08/22/2002 |
Decision Date | 06/28/2004 |
Conversion Date
|
08/14/2013 |
Product Code |
MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE TERMINATION OF THE POST-APPROVAL STUDY PROTOCOL ENTITLE: "A RANDOMIZED, CONTROLLED WITHIN-PATIENT-PAIRED STUDY TO COMPARE THE EFFECTIVENESS OF TRANSCYTE AND BIOBRANE IN THE TREATMENT OF MID-DERMAL TO INDETERMINATE DEPTH BURN WOUNDS." |