{"publicDeviceRecordKey":"37b39557-a0ee-49f9-a6b8-f9a792f6e62c","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2019-10-07T00:00:00.000Z","devicePublishDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08714729806387","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Emerge™","versionModelNumber":"H7493918920400","catalogNumber":null,"dunsNumber":"021717889","companyName":"BOSTON SCIENTIFIC CORPORATION","deviceCount":1,"deviceDescription":"PTCA Dilatation Catheter","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47732","gmdnPTName":"Coronary angioplasty balloon catheter, basic","gmdnPTDefinition":"A 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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LOX","productCodeName":"Catheters, transluminal coronary angioplasty, percutaneous"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"4.00 mm Diameter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"20 mm Length"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}