<?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>ef1b4788-6928-46a3-bdfc-d29567e63487</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2020-01-31</publicVersionDate><devicePublishDate>2020-01-23</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08714729937814</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>Tria™ Firm</brandName><versionModelNumber>M0061902150</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>021717889</dunsNumber><companyName>BOSTON SCIENTIFIC CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>Ureteral Stent Braided Suture w/Side Holes 4.8Fx30CM</deviceDescription><DMExempt>false</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>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Safe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>58005</gmdnCode><gmdnPTName>Polymeric ureteral stent</gmdnPTName><gmdnPTDefinition>A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FAD</productCode><productCodeName>Stent, ureteral</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Stent Length</sizeType><size unit="Centimeter" value="30"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Stent Diameter</sizeType><size unit="Millimeter" value="1.6"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>4.8F</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>