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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 Quartz Contact Force Ablation Catheter
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 NumberS069
Date Received02/05/2021
Decision Date08/03/2021
Product Code OAE 
Advisory Committee Cardiovascular
Clinical TrialsNCT02310100
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a labeling update for the TactiCath Quartz Contact Force Ablation Catheter Instructions for Use to included a summary of the long-term effectiveness data from the TactiCath Quartz Post-Approval Study.
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