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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/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.
 
DeviceCOLLASTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536
PMA NumberP810006
Date Received03/02/1981
Decision Date12/10/1981
Product Code LMF 
Docket Number 81M-0402
Notice Date 01/05/1982
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S011 S012 S013 
S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 
S064 S065 S068 S070 S071 S072 S073 S074 S075 S076 S077 S078 
S079 S080 S081 S082 S083 S084 S085 S086 S087 S088 S089 S090 
S091 S092 S093 S094 S095 S096 S097 S098 S099 S100 S101 S102 
S103 S104 S105 S106 
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