<?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>c8327268-8fb8-4c67-a322-55db7e1e3b72</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2016-12-16</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00650551076216</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>CORTAC®</brandName><versionModelNumber>2110TX-16-035-NS</versionModelNumber><catalogNumber>2110TX-16-035-NS</catalogNumber><dunsNumber>039576871</dunsNumber><companyName>PMT CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, 2X8, ALL CONTACTS RADIOPAQUE, TEXTURED, INLINE CONNECTOR, 1 EXIT, TOP &amp; BOTTOM ROWS NUMBERED
</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>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>800-626-5463</phone><phoneExtension xsi:nil="true"/><email>info@pmtcorp.com</email></customerContact><customerContact><phone>800-626-5463</phone><phoneExtension xsi:nil="true"/><email>intl@pmtcorp.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K082474</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>32545</gmdnCode><gmdnPTName>Cortical electrode</gmdnPTName><gmdnPTDefinition>A sterile, invasive, electrical conductor that is temporarily placed (&lt; 30 days) on the surface of the brain to stimulate the brain or to record the brain&apos;s electrical activity (with more precise localization than a scalp electrode). It is typically a series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GYC</productCode><productCodeName>Electrode, Cortical</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Contact Diameter 3 Millimeter</sizeText></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Thickness 0.76 Millimeter</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Hydrogen Peroxide</sterilizationMethod></methodTypes></sterilization></device>