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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.
 
DeviceION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP100023
Supplement NumberS069
Date Received02/01/2013
Decision Date05/15/2013
Withdrawal Date12/06/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BALLYBRIT BUSINESS PARK, IN GALWAY, IRELAND.
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