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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: S022 S013 S015  S031 S033 S025 S017 S018 S019 S024 S029 
S009 S003 S005 S004 S007 S001 S012 S020 S023 S030 S032 S016 
S028 S027 S008 S010 S002 S006 S011 S034 S035 S036 S041 S037 
S045 S042 S043 S053 S050 S051 S054 S055 S048 S040 S039 S038 
S044 S056 S057 S047 S049 S052 S046 S058 S059 
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