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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.
 
DeviceTHERMOCOOL SMARTTOUCH® SF
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP040036
Supplement NumberS091
Date Received12/19/2022
Decision Date08/03/2023
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the Instructions for Use (IFU) for the THERMOCOOL SMARTTOUCH® and SMARTTOUCH® SF Catheters that allow for the use of direct imaging guidance, such as fluoroscopy or ultrasound, during catheter manipulation; the changes are being made based on clinical data from the REAL AF Registry Sub-Study.
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