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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 NameSTINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE
Classification Namecardiac ablation percutaneous catheter
Generic Namerf ablation catheter
ApplicantC.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION
PMA NumberP000020
Date Received05/04/2000
Decision Date11/29/2000
Product Code
LPB[ Registered Establishments with LPB ]
Docket Number 01M-0460
Notice Date 10/11/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 
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