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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP020025
Supplement NumberS051
Date Received11/21/2013
Decision Date12/18/2013
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
VENDOR MANUFACTURING CHANGES FOR THE BLAZER II, BLAZER II HTD, BLAZER PRIME HTD, BLAZER II XP, AND BLAZER PRIME XP ABLATION CATHETERS.
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