<?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>dc0339d0-2114-4a54-9b37-35f4423c9088</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2026-09-23</publicVersionDate><devicePublishDate>2023-12-31</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00847536036734</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>PipelineTM Vantage Embolization Device with Shield TechnologyTM</brandName><versionModelNumber>PED3-027-400-25</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>826110710</dunsNumber><companyName>Micro Therapeutics, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>STENT PED3-027-400-25 V03 VANTAGE</deviceDescription><DMExempt>true</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)633-8766</phone><phoneExtension xsi:nil="true"/><email>Corporate.UDI@medtronic.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>P100018</submissionNumber><supplementNumber>034</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>46352</gmdnCode><gmdnPTName>Bare-metal intracranial vascular stent</gmdnPTName><gmdnPTDefinition>A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)]; it does not include a polymer tube (i.e., not a stent-graft). Disposable devices associated with implantation (e.g., balloon catheter) may be packaged with the stent.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>OUT</productCode><productCodeName>Intracranial aneurysm flow diverter</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>