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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
Applicant
St. Jude Medical
one st. jude medical drive
st. paul, MN 55117
PMA NumberP130026
Supplement NumberS047
Date Received05/22/2019
Decision Date06/19/2019
Product Code OAE 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Process change to aid in assembly of the device.
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