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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 SURESHOT ARTERIAL CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantSUB-Q, INC.
PMA NumberP010049
Supplement NumberS010
Date Received12/02/2003
Decision Date05/25/2004
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the design of the quickseal arterial closure system to allow the delivery of q-foam hemostatic sponge through an introducer delivery sheath and eliminate the depth market component. The device, as modified, will be marketed under the trade name quickseal sureshot and is indicated for use in reducing time to hemostatis at femoral artery puncture sites and in reducing time to ambulation in patients who have undergone diagnostic or interventional procedures using 8 french or smaller procedural sheaths. The device reduces time to eligibility for hospital discharge in patients who have undergone diagnostic or interventional procedures and reduces time to actual hospital discharge in patients who have undergone diagnostic procedures.
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