PMA P960007S017

Device: TRANSCYTE
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S017
Product code: MGR
Decision date: 2004-06-28
Generic name: Dressing, wound and burn, interactive
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."

Current openFDA PMA Record#

Device: TRANSCYTE
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S017
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2004-06-28
Decision code: APPR
Date received: 2002-08-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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."