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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 NameBLAZERII TEMPERATURE ABLATION CATHETER, BLAZERII XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATION
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency generator/cardiac ablation catheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP020025
Supplement NumberS040
Date Received03/21/2013
Decision Date04/18/2013
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Introduce and allow the use of a new test fixture for the out-of-plane inspection.
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