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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, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS AND TEMPLINK EXTENSION CABLES
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp.
55 technology drive
lowell, MA 01851
PMA NumberP000020
Supplement NumberS012
Date Received03/31/2009
Decision Date04/21/2009
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the stinger, stinger s, scorpion, scorpion *2 ablation catheters with the boston scientific maestro 3000, ept-1000xp, and irvine biomedical ibi-1500 t9 and ibi-150 t6 rf generators.
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