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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 & CABLE
Classification Namecardiac ablation percutaneous catheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP920047
Supplement NumberS050
Date Received11/07/2011
Decision Date12/05/2011
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Software and equipment hardware updates to a sterilization chamber at the coventry, rhode island facility.
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