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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSTINGER(TM) M ABLATION CATHETER/TEMPLINK(TM) M EXTENSION CABLE
Classification Namecardiac ablation percutaneous catheter
Generic Namerf diagnostic/ablation catheter
ApplicantC.R. BARD, INC.
PMA NumberP000020
Supplement NumberS002
Date Received01/09/2001
Decision Date02/07/2001
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the stinger m ablation catheter (models 210001m - 210006m) and the templink m cable (model 210078m). The devices are indicated for creating focal endocardial lesions during cardiac ablation procdures to treat arrhythmias and for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli.
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