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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 SM ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Namerf diagnostic/ablation catheter
ApplicantC.R. BARD, INC.
PMA NumberP000020
Supplement NumberS004
Date Received08/24/2001
Decision Date10/10/2001
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of another ablation catheter model to the existing stinger(tm) product line. The device, as modified, will be marketed under the trade name stinger(tm) sm ablation catheter and is indicated for creating focal endocardial lesions during cardiac ablation procedures to treat arrhythmias and for cardiac electrophysiological mapping and delivering diagnostic stimuli.
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