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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.
 
DeviceFLEXTOME CORONARY CUTTING BALLOON
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP950020
Supplement NumberS061
Date Received03/29/2013
Decision Date06/21/2013
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to manufacture the flushing needle (also known as tip barrell 30 gauge) accessory with an alternative resin provided by a new supplier.
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