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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.
 
DeviceHELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08540
PMA NumberP850010
Date Received02/20/1985
Decision Date11/08/1985
Product Code LMF 
Docket Number 85M-0557
Notice Date 01/02/1986
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements: S001 S002 S003 S004 S005 S006 S007 S010 S011 S012 S013 S014 
 S015 S049 S033 S046 S047 S048 S037 S038 S039 S040 S041 
S029 S016 S025 S018 S017 S020 S071 S075 S055 S056 S058 S059 
S060 S061 S062 S031 S032 S034 S035 S036 S057 S067 S050 S051 
S052 S053 S054 S063 S064 S042 S043 S044 S045 S026 S027 S021 
S028 S022 S023 S024 S019 S030 S069 S070 S074 S073 S072 S077 
S080 S089 S085 S086 S087 S088 S095 S096 S102 S108 S092 S093 
S076 S078 S079 S081 S082 S084 S091 S083 S090 S105 S098 S106 
S107 S094 S097 S100 S101 S103 S104 S099 S109 
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