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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLivewire™ TC XLS™
Generic NameCardiac ablation percutaneous catheter
ApplicantSt Jude Medical
14900 Minnetonka Ind Rd.
Minnetonka, MN 55345
PMA NumberP960016
Supplement NumberS093
Date Received12/17/2025
Decision Date01/15/2026
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
an alternate vapor degreaser which is used as a processing aid to remove metalworking cutting fluid on patient-contacting tip electrodes and electrode rings during manufacturing
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