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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 Smart Touch SF Bi-Directional Navigation Catheter & ThermoCool Smart Touch SF Uni-Direcional Navigation Cathe
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS088
Date Received06/21/2018
Decision Date07/18/2018
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Additional sensor coil quality control test for ThermoCool SmartTouch SF Uni-Directional Navigation Catheters and the ThermoCool SmartTouch SF Bi-Directional Navigation Catheters.
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