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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.
 
DeviceStockert SMARTABLATE System
Generic NameCardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP990071
Supplement NumberS046
Date Received10/27/2020
Decision Date09/23/2021
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new manufacturing site located at STOCKERT GMBH, Boetzinger Strasse 31, Freiburg, Baden-Wurttemberg, Germany D-79111 for the manufacturing of the SMARTABLATE® System (which consists of the SMARTABLATE® Radiofrequency (RF) Generator, SMARTABLATE® Remote Control, SMARTABLATE® Irrigation Pump).
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