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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.
 
DeviceAngio Seal Vascular Closure Device
Generic NameDevice, hemostasis, vascular
ApplicantTERUMO MEDICAL CORPORATION
950 ELKTON BLVD.
ELKTON, MD 21921
PMA NumberP930038
Date Received10/28/1993
Decision Date09/30/1996
Product Code MGB 
Docket Number 97M-0259
Notice Date 07/10/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
Supplements:  S001 S002 S004 S005 S006 S007 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S054 S055 S057 S058 S060 S061 S062 S063 S064 S065 
S066 S067 S068 S069 S070 S071 S072 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 
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