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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.
 
Device Apligraf
Classification Namecultured human cell skin dressing
Generic Namepfc
Applicant
Organogenesis, Inc.
150 dan road
Canton , MA 02021 
  
PMA NumberBP953200
Date Received10/04/1995
Decision Date05/22/1998
Decision Approved
Product Code
PFC[ Registered Establishments with PFC ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S002 S004 S007 S008 S009 S010 S011 S014 S015 
S016 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 S071 S072 S073 S074 S076 
S077 S078 S080 S081 S082 S083 S084 S085 S086 
S087 S088 S090 S091 S092 S093 S094 S095 S096 
S097 S098 S101 S104 S105 S107 S108 S109 S110 
S112 S114 S116 S117 S118 S119 S121 S122 S123 
S124 S125 S126 S127 S129 S132 S133 S136 S140 
S142 
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