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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namefemoral artery puncture closing device
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP930038
Date Received10/28/1993
Decision Date09/30/1996
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 97M-0259
Notice Date 07/10/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 
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