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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 IIXP/BLAZER PRIME XP ABLATION CATHETERS AND EPT-1000 XP CARDIAC ABLATION CONTROLLER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St Paul, MN 55112
PMA NumberP020025
Supplement NumberS048
Date Received09/23/2013
Decision Date10/23/2013
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE QUALITY CONTROL (QC) INSPECTIONS OF THE CARDIAC ABLATION SYSTEM CABLES.
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