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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAPLIGRAF (GRAFTSKIN)
Classification Namedressing, wound and burn, interactive
Generic Namegraftskin
ApplicantORGANOGENESIS, INC.
PMA NumberP950032
Date Received10/04/1995
Decision Date05/22/1998
Conversion Date 08/08/2013
Product Code
MGR[ Registered Establishments with MGR ]
Docket Number 98M-0992
Notice Date 12/17/1998
Advisory Committee General & Plastic Surgery
Expedited Review Granted? Yes
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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 
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