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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
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 NumberS028
Date Received12/15/2017
Decision Date03/26/2018
Product Code OAE 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to receiving inspection and manufacturing procedures for tests related to the FISO module and force testing.
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