DevicePMAs@therightstef:P930038_S052 JSONTXT 13 Projects

Approval for use of the angio-seal vascular closure device in closure of femoral venous puncture sites and for the removal of the precaution statement relating to the use of the anticoagulant warfarin. The device, as modified, will be marketed under the trade name angio-seal vascular closure device and is indicated for use in closing and in reducing time to hemostasis at the femoral arterial and femoral venous puncture site in patients who have undergone diagnostic angiography or percutaneous transluminal coronary angioplasty (ptca) procedures using an 8 french or smaller procedural sheath.