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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.
 
DeviceCOLLACOTE(TM)
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantINTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536
PMA NumberP840062
Date Received11/23/1984
Decision Date11/08/1985
Product Code LPG 
Docket Number 85M-0556
Notice Date 01/02/1986
Advisory Committee Dental
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements: S006 S037  S001 S002 S003 S004 S025 S035 S036 S029 S030 
S010 S013 S014 S015 S016 S011 S018 S019 S020 S008 S009 S007 
S054 S059 S060 S062 S042 S043 S044 S045 S046 S047 S048 S023 
S024 S026 S027 S028 S052 S038 S039 S040 S041 S049 S031 S032 
S033 S034 S021 S017 S012 S055 S056 S061 S058 S057 S063 S065 
S071 S076 S069 S086 S082 S079 S083 S089 S090 S066 S067 S064 
S072 S073 S074 S075 S077 S070 S068 S080 S081 S084 S085 S078 
S087 S088 S091 S022 
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