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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceMAESTRO 3000 CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp.
150 baytech drive
san jose, CA 95134
PMA NumberP980003
Supplement NumberS045
Date Received10/31/2013
Decision Date12/05/2013
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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