DevicePMAs@therightstef:P020035_S000 JSONTXT 11 Projects

Approval for the x-press 6 french vascular closure system. The device is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using sheaths less than or equal to 6 french in size. The device is intended to reduce the time to hemostasis, time to ambulation (100 feet), and time to dischargeability in patients who have undergone diagnostic or interventional cardiac catheterization procedures without complicating clinical conditions, including those patients receiving glycoprotein iib/iiia inhibitors.