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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.
 
DeviceSURGICEL BRAND ABSORBABLE HEMOSTAT
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
1000 Route 202
Raritan, NJ 08869
PMA NumberN12159
Date Received10/14/1960
Decision Date10/14/1960
Product Code LMG 
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S005 S006 S007 S008 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S023 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 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 S072 S073 S074 S075 S076 S077 
S078 S079 S080 S081 S082 S083 S084 S085 S086 S087 S088 S089 
S090 S091 S092 S094 S096 S098 S099 S100 S101 S103 S104 S105 
S106 S107 S108 
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