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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.
 
DeviceSTINGER(TM) AND STINGER S(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp.
55 technology drive
lowell, MA 01851
PMA NumberP000020
Supplement NumberS001
Date Received01/08/2001
Decision Date05/18/2001
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the materials of the catheter tip to increase its stiffness and other minor device modifications. The device, as modified, will be marketed under the trade name stin s 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 pacing stimuli.
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