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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.
Classification Namecardiac ablation percutaneous catheter
Generic Namerf diagnostic/ablation catheter
ApplicantC.R. BARD, INC.
PMA NumberP000020
Supplement NumberS010
Date Received08/01/2005
Decision Date02/16/2006
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a second articulation to the stinger s/stinger sm line of rf ablation catheters. The device, as modified, will be marketed under the trade name scorpion/scorpion m, and is indicated for creating focal endocardial lesions during cardiac ablation procedures to treat arrhythmias, and for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli. In addition, approval for a change in the indications for use of the templink/ templink m connection cables to include the scorpion/scorpion m catheters in the list of catheters with which it can be used.