<?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>edecfb55-c798-4498-a4d1-92f1b198f4bc</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2019-09-23</publicVersionDate><devicePublishDate>2016-11-17</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00650551092971</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>PMT® CORPORATION - SPHENOIDAL</brandName><versionModelNumber>2102-32-06-NS</versionModelNumber><catalogNumber>2102-32-06-NS</catalogNumber><dunsNumber>039576871</dunsNumber><companyName>PMT CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
</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>K033730</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>32556</gmdnCode><gmdnPTName>Depth electrode</gmdnPTName><gmdnPTDefinition>An electrical conductor intended to be temporarily placed (&lt; 30 days) beneath 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 fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GZL</productCode><productCodeName>Electrode, Depth</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Recording Length 0.25 Inch</sizeText></deviceSize><deviceSize><sizeType>Needle Gauge</sizeType><size unit="Gauge" value="22"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Tip Size 3-5 Millimeter</sizeText></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="30"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Wire Gauge 36 Gauge</sizeText></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="78"/><storageHandlingLow unit="Degrees Fahrenheit" value="58"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Hydrogen Peroxide</sterilizationMethod></methodTypes></sterilization></device>