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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSTOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
Generic NameCardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP990071
Date Received11/09/1999
Decision Date05/31/2000
Product Code LPB 
Docket Number 03M-0045
Notice Date 03/01/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
THE STOCKERT 70 RF GENERATOR SYSTEM IS INDICATED FOR USE WITH A BIOSENSE WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER TO DELIVER RF ENERGY DURING CARDIAC ABLATION PROCEDURES.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S029 S015  S012 S013 S031 S025 S022 S023 S006 S004 S005 
S003 S009 S002 S033 S001 S020 S028 S017 S018 S019 S016 S030 
S032 S027 S024 S007 S008 S010 S011 S034 S035 S036 S038 S044 
S045 S048 S054 S052 S057 S039 S037 S040 S041 S042 S043 S056 
S053 S050 S047 S055 S049 S046 S051 S058 S059 
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