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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
ApplicantDAVIS & GECK, INC.
PMA NumberP930038
Supplement NumberS010
Date Received11/25/1997
Decision Date06/03/1998
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the instructions for use to include a secondary manual tamp during deployment of the device.
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