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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.
 
DeviceTatiCath Quartz Contact Force Ablation Catheter
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantSt. Jude Medical
One St. Jude Medical Drive
St. Paul, MN 55117
PMA NumberP130026
Supplement NumberS031
Date Received02/12/2018
Decision Date03/12/2018
Product Code OAE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implementation of parametric release method at specified cycles and chambers.
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