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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 PRIME HTD CATHETER
Classification Namecardiac ablation percutaneous catheter
ApplicantBOSTON SCIENTIFIC
PMA NumberP920047
Supplement NumberS042
Date Received06/02/2010
Decision Date06/30/2010
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a 70% isopropyl alcohol wipe in the manufacturing process.
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