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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 AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency generator/cardiac ablation catheter
ApplicantBOSTON SCIENTIFIC
PMA NumberP020025
Supplement NumberS067
Date Received01/13/2015
Decision Date04/06/2015
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design change to system cables from lead containing solder to lead-free solder.
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