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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSTOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
Classification Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency generator and accessories/accessory cable
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990071
Date Received11/09/1999
Decision Date05/31/2000
Product Code
LPB[ Registered Establishments with LPB ]
Docket Number 03M-0045
Notice Date 03/01/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S010 S011 S012 S013 
S015 S016 S017 S018 S019 S020 
S022 
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