|Trade Name||QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM|
|Classification Name||device, hemostasis, vascular|
|Generic Name||vascular hemostasis device|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| 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.