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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 NameQUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantSUB-Q, INC.
PMA NumberP010049
Supplement NumberS009
Date Received10/03/2003
Decision Date12/23/2003
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to reduce the minimum required access site depth from 3 centimeters to 2 centimeters in the instructions for use.
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