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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 XP,BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency generator/cardiac ablation catheter
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP020025
Supplement NumberS055
Date Received03/06/2014
Decision Date04/04/2014
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Acceptance for bioburden testing to be completed at an alternate facility.
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