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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.
 
DeviceSTINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
55 TECHNOLOGY DRIVE
LOWELL, MA 01851
PMA NumberP000020
Date Received05/04/2000
Decision Date11/29/2000
Product Code LPB 
Docket Number 01M-0460
Notice Date 10/11/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE STINGER(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE. THE DEVICE IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS, AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 
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