DevicePMAs@therightstef:P060006_S000 JSONTXT

Approval for the boston scientific express sd renal monorail premounted stent system. The device is indicated as an adjunct to percutaneous transluminal renal angioplasty (ptra) of a single de novo or restenotic atherosclerotic lesion (<=15 mm in length) of the renal artery, located within 5 mm of the opacified aortic lumen, with a reference vessel diameter of 4.0 7.0 mm to assist in the maintenance of vessel patency.