|Trade Name||VASOSEAL ES DEVICE|
|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 market a modified version of the vasoseal(r) vascular hemostasis device. The device, as modified, will be marketed under the trade name vasoseal(r) extra security (es) device and is indicated for reducing time to hemostasis at the femoral arterial puncture site and in reducing time to ambulation in patients who have undergone diagnostic angiography or interventional procedures.