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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.
 
Trade NameMAESTRO 3000 CARDIAC ABLATION SYSTEM
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
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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