|Trade Name||ANGIO-SEAL(TM) HEMOSTATIC PUNCTURE CLOSURE DEVICE|
|Classification Name||device, hemostasis, vascular|
|Generic Name||femoral artery puncture closing device|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the indications for use for the angio-seal(tm) device. The angio-seal(tm) hemostatic puncture closure device is now indicated for use in closing and in reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography or interventional procedures using an retrograde approach and an 8 french or smaller procedural sheath.