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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.
 
DeviceEPT-1000 XP CARDIAC ABLATION SYSTEM CONTROLLER AND ACCESSORIES AND MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St Paul, MN 55112
PMA NumberP020025
Supplement NumberS022
Date Received01/26/2010
Decision Date02/22/2010
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 TO INCOMING ACCEPTANCE TEST METHODS.
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