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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 Drive
St. Paul, MN 55117
PMA NumberP130026
Supplement NumberS070
Date Received04/01/2021
Decision Date11/04/2021
Product Code OAE 
Advisory Committee Cardiovascular
Clinical TrialsNCT03650556
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the TactiCath Contact Force Ablation Catheter, Sensor Enabled. The device is indicated for use in cardiac electrophysiology mapping and for the treatment of drug refractory recurrent symptomatic, paroxysmal, and persistent atrial fibrillation, when used in conjunction with a compatible RF generator and three-dimensional mapping system.
Post-Approval StudyShow Report Schedule and Study Progress
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