<?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>1e03f57d-e662-4c84-8f38-40e8d8638058</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2026-01-07</publicVersionDate><devicePublishDate>2018-08-17</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00643169630505</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>SYNCHROMED® II</brandName><versionModelNumber>8637-20</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>006261481</dunsNumber><companyName>MEDTRONIC, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>PUMP 8637-20 SYNCHMED II 20ML EMAN SYMBL</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>true</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</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>P860004</submissionNumber><supplementNumber>268</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>46024</gmdnCode><gmdnPTName>Implantable intrathecal infusion pump, programmable</gmdnPTName><gmdnPTDefinition>A battery-powered programmable device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) delivers drug doses from its implanted refillable reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. The drug reservoir, usually implanted under the skin of the lower abdomen, is typically connected to a catheter placed into the spinal fluid space.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LKK</productCode><productCodeName>PUMP, INFUSION, IMPLANTED, PROGRAMMABLE</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Reservoir Volume 20 mL</sizeText></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="86"/><storageHandlingLow unit="Degrees Fahrenheit" value="59"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="30"/><storageHandlingLow unit="Degrees Celsius" value="15"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="131"/><storageHandlingLow unit="Degrees Fahrenheit" value="41"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="55"/><storageHandlingLow unit="Degrees Celsius" value="5"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Keep away from magnets</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>