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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 NameBLAZER II CARDIAC ABLATION CATHETER AND CABLE
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
PMA NumberP920047
Supplement NumberS051
Date Received03/23/2012
Decision Date04/19/2012
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an existing process to an existing sterilization equipment.
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