<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>68d7bd85-eeb5-48fd-b7fd-f0b7f71b53fa</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>8</publicVersionNumber><publicVersionDate>2023-03-29</publicVersionDate><devicePublishDate>2017-11-03</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00802526533761</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>ORIGEN™ MINI ICD DR</brandName><versionModelNumber>D003</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>106295384</dunsNumber><companyName>BOSTON SCIENTIFIC CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>Implantable Cardioverter Defibrillator DR</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><premarketSubmissions><premarketSubmission><submissionNumber>P960040</submissionNumber><supplementNumber>394</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>P960040</submissionNumber><supplementNumber>395</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>P960040</submissionNumber><supplementNumber>398</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>P960040</submissionNumber><supplementNumber>438</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>P960040</submissionNumber><supplementNumber>440</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>P960040</submissionNumber><supplementNumber>459</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>P960040</submissionNumber><supplementNumber>484</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>37265</gmdnCode><gmdnPTName>Dual-chamber implantable defibrillator</gmdnPTName><gmdnPTDefinition>A battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and to pace the heart (to treat bradycardia). It is implanted in a pouch beneath the skin of the patient&apos;s chest or abdomen and intended to be used with leads that are positioned inside the right atrium and right ventricle to monitor the ECG and to automatically deliver the electrical impulse; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LWS</productCode><productCodeName>Implantable cardioverter defibrillator (non-CRT)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>