abb5b485-81a7-404b-b9ff-8ee259334029UpdatePublished42020-06-292016-07-01In Commercial Distribution08033477057255PrimaryGS1ADMIRAL XTREMEADM120040080006261481MEDTRONIC, INC.1CATH ADM120040080 ADM US 12 00L40 UL0800falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK06280900017184Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.falseActiveDQYCATHETER, PERCUTANEOUSOuter DiameterLengthSpecial Storage Condition, SpecifyStore at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.truefalse