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: APLIGRAF (GRAFTSKIN)
• Generic Name: Dressing, wound and burn, interactive
• Applicant: ORGANOGENESIS, INC.; 150 DAN RD.; CANTON, MA 02021
• PMA Number: P950032
• Date Received: 10/04/1995
• Decision Date: 05/22/1998
• Conversion Date: 08/14/2013
• Product Code: MGR
• Docket Number: 98M-0992
• Notice Date: 12/17/1998
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: Yes
• Combination Product: Yes
• Recalls: CDRH Recalls

Approval Order Statement  
This device is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S004 S007 S008 S009 S010 S011 S014 S015 S016 ; S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 ; S029 S031 S032 S033 S034 S035 S036 S037 S038 S040 S041 S043 ; S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 ; S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S066 S067 ; S068 S069 S070 S071 S072 S073 S074