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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 TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI
Classification Namecardiac ablation percutaneous catheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP920047
Supplement NumberS058
Date Received03/25/2013
Decision Date07/22/2013
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to move the extrusion process for blazer prime ablation catheters to a new manufacturing line introducing an automated process to identify and cut marked sections of the extruded shaft.
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