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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 SET
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 NumberS015
Date Received01/21/2016
Decision Date02/19/2016
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the definition of the LSI multi-parameter index in the TactiSys Quartz Instructions for Use document.
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