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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION)
Classification Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency generator and accessories/accessory cable
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990071
Supplement NumberS027
Date Received04/07/2014
Decision Date07/02/2014
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for hardware modifications to the smartablate irrigation pump that update the hardware from version 1 to version 2.
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