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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 CARDIAC ABLATION SYSTEM
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
BOSTON SCIENTIFIC
150 baytech drive
san jose, CA 95134
PMA NumberP020025
Supplement NumberS049
Date Received10/31/2013
Decision Date12/05/2013
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MINOR LABELING CHANGES, INCLUDING UPDATES IN ACCORDANCE WITH IEC 60601-1 THIRD EDITION.
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