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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 NameCOOLFLOW TUBING IFU
Classification Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency generator and accessories/accessory cable
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990071
Supplement NumberS011
Date Received03/17/2010
Decision Date04/07/2010
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the labeling made to the coolflow irrigation pump¿s tubing set.
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