{"publicDeviceRecordKey":"13ea325a-8561-486f-8020-c8786a2d958f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2020-07-20T00:00:00.000Z","devicePublishDate":"2016-04-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033477035536","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PACIFIC XTREME","versionModelNumber":"PCU050250130","catalogNumber":null,"dunsNumber":"006261481","companyName":"MEDTRONIC, INC.","deviceCount":1,"deviceDescription":"Cath PCU050250130 PCU US 05.00L250UL1300","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)633-8766","phoneExtension":null,"email":"Corporate.UDI@medtronic.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K103464","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17184","gmdnPTName":"Peripheral angioplasty balloon catheter, basic","gmdnPTDefinition":"A 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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LIT","productCodeName":"Catheter, angioplasty, peripheral, transluminal"},{"productCode":"DQY","productCodeName":"CATHETER, PERCUTANEOUS"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"5.0"},"sizeText":null,"sizeString":"Outer Diameter: 5.0 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"250.0"},"sizeText":null,"sizeString":"Length: 250.0 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store at controlled room temperature, in a dry place.  Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light."}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}