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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.
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Boston Scientific Corp.
55 technology drive
lowell, MA 01851
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
Recalls CDRH 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 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 S014 S015 S016 S017 S018