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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.
 
DeviceBLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
BOSTON SCIENTIFIC
150 baytech drive
san jose, CA 95134
PMA NumberP020025
Supplement NumberS052
Date Received01/09/2014
Decision Date02/07/2014
Product Code
OAD[ Registered Establishments with OAD ]
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 
Automate and move an extrusion process for the blazer prime xp & intellatip mifi xp temperature ablation catheters to a different manufacturing line.
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