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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 Namecardiac ablation percutaneous catheter
Boston Scientific Corp.
150 baytech drive
san jose, CA 95134
PMA NumberP920047
Supplement NumberS047
Date Received06/09/2011
Decision Date07/19/2011
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 packaging design change for the blazer ii/prime htd catheters electrophysiology cables, models m0046130 and m0046510; chilli cooled ablation system electrophysiology cables, models m0046810 and m004620620; and blazer ii xp and blazer prime cardiac ablation catheters electrophysiology cables, models m0046130 and m0046510.