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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 Dr.
St. Paul, MN 55117
PMA NumberP130026
Supplement NumberS043
Date Received03/12/2019
Decision Date04/10/2019
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the reduction of the concentration of IPA in all TactiCath SE manufacturing.
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