804312d1-95a8-4a81-9568-da8a2cc2ca79NewPublished12025-09-292025-09-19In Commercial Distribution00763000877484PrimaryGS1SPRINTER® LEGENDSPL35025X006261481MEDTRONIC, INC.1BALLOON SPL35025X SPR LEG RX US MfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK10309500047732Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.falseActiveLOXCatheters, transluminal coronary angioplasty, percutaneousBalloon DiameterDevice Size Text, specifyDistal Shaft (Proximal): 2.6 FDevice Size Text, specifyDistal Shaft Outer Diameter: 2.4 FBalloon Lengthtruefalse