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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
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Applicant
St. Jude Medical
one st. jude medical drive
st. paul, MN 55117
PMA NumberP130026
Supplement NumberS036
Date Received09/27/2018
Decision Date12/27/2018
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the TactiCath Contact Force Ablation Catheter, Sensor Enabled. The device is indicated for use in cardiac electrophysiological mapping and forthe treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible RFgenerator and three-dimensional mapping system.
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