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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.
 
DeviceSTOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, CA 91765
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
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S015 S016 S017 S018 S019 
S020 S022 S023 S024 S025 S027 S028 S029 S030 
S031 S032 
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