{"publicDeviceRecordKey":"944332d3-8274-4b8a-82f7-5689219201cd","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":8,"publicVersionDate":"2023-03-31T00:00:00.000Z","devicePublishDate":"2017-11-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00802526534492","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ORIGEN™ X4 CRT-D","versionModelNumber":"G056","catalogNumber":null,"dunsNumber":"106295384","companyName":"BOSTON SCIENTIFIC CORPORATION","deviceCount":1,"deviceDescription":"Cardiac Resynchronization Therapy Defibrillator","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"P010012","supplementNumber":"451"},{"submissionNumber":"P010012","supplementNumber":"453"},{"submissionNumber":"P010012","supplementNumber":"458"},{"submissionNumber":"P010012","supplementNumber":"504"},{"submissionNumber":"P010012","supplementNumber":"506"},{"submissionNumber":"P010012","supplementNumber":"528"},{"submissionNumber":"P010012","supplementNumber":"560"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47270","gmdnPTName":"Cardiac resynchronization therapy implantable defibrillator","gmdnPTDefinition":"An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NIK","productCodeName":"Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)"}]},"deviceSizes":{"deviceSize":[]},"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}