Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: INTEGRA DERMAL REGENERATION TEMPLATE
• Generic Name: Dressing, wound and burn, interactive
• Applicant: Integra LifeSciences Corp.; 105 MORGAN LN.; PLAINSBORO, NJ 08536
• PMA Number: P900033
• Date Received: 05/07/1990
• Decision Date: 03/01/1996
• Product Code: MGR
• Docket Number: 96M-0203
• Notice Date: 07/18/1996
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE INTEGRA ARTIFICAL SKIN

• Supplements: S021 S001 S047 S048 S042 S043 S022 S023 S024 S025 S003 ; S005 S012 S033 S035 S031 S053 S013 S016 S006 S007 S011 S002 ; S010 S017 S018 S009 S055 S059 S061 S020 S026 S027 S028 S038 ; S039 S040 S041 S037 S044 S045 S029 S030 S032 S054 S051 S046 ; S034 S019 S014 S008 S015 S062 S063 S060 S058 S056 S057 S072 ; S077 S078 S079 S080 S089 S092 S098 S103 S095 S096 S101 S102 ; S106 S094 S071 S070 S067 S073 S068 S069 S065 S066 S081 S082 ; S083 S084 S085 S086 S075 S076 S090 S074 S107 S104 S105 S099 ; S100 S110 S093 S097 S091 S111 S108 S109