|Trade Name||SURESTAT ARTERIAL CLOSURE SYSTEM|
|Classification Name||device, hemostasis, vascular|
|Generic Name||vascular hemostasis device|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to add a polysaccharide (chitosan) to the hemostatic pledget formulation and requested to rename the device from the quickseal surestat arterial closure system to the surestat arterial closure system. The device, as modified, will be marketed under the trade name surestat arterial closure system and is indicated for "delivery of t-foam for extravascular closure of the femoral artery access sites. The system is indicated for use in reducing time to hemostasis 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. ".