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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.
 
DeviceMAESTRO 3000 TM CARDIAC ABLATION SYSTEM
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP020025
Supplement NumberS012
Date Received07/18/2005
Decision Date10/18/2005
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODIFICATION TO THE HARDWARE, SOFTWARE, AND NEW ACCESSORIES OF THE EPT-1000 SERIES OF CARDIAC ABLATION SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAESTRO 3000 CARDIAC ABLATION SYSTEM AND IS INDICATED FOR USE, IN CARDIAC ABLATION PROCEDURES, WITH STANDARD AND HIGH-POWER BSC CARDIAC ABLATION CATHETERS SUCH THAT THE PHYSICIAN IS REFERRED TO THE INDIVIDUAL INSTRUCTIONS FOR USE FOR CATHETER COMPATIBILITY TO THE MAESTRO 3000 CARDIAC ABLATION SYSTEM. THE BOSTON SCIENTIFIC CORPORATION ABLATION CATHETERS WHICH ARE COMPATIBLE WITH THE MAESTRO CARDIAC ABLATION SYSTEM ARE THE BLAZER II/BLAZER II HTD, BLAZER II XP, BLAZER RPM , BLAZER XP RPM, POLARIS T/POLARIS T HTD, CHILLI II, AND STEEROCATH-T.
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