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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.
 
DeviceFLEXTOME CORONARY CUTTING BALLOON
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP950020
Supplement NumberS061
Date Received03/29/2013
Decision Date06/21/2013
Product Codes MAF NIN NIQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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