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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namefemoral artery puncture closing device
ApplicantTHE KENDAL CO.
PMA NumberP930038
Supplement NumberS017
Date Received08/07/1998
Decision Date09/25/1998
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to packaging system components (i. E. , insulated shipping container, ice pack, component tray and guidewire tray) of the angio-seal(tm) device.
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