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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.
 
DeviceTactiCath Contact Force Ablation Catheter, Sensor Enabled
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantSt Jude Medical
One St. Jude Medical Dr.
St. Paul, MN 55117
PMA NumberP130026
Supplement NumberS067
Date Received11/27/2020
Decision Date12/18/2020
Product Code OAE 
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  
changes to the TactiCath SE process aid to prevent adhesive contamination on the tip electrode
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