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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.
 
DeviceEluvia Drug-Eluting Vascular Stent System
Generic NameStent, superficial femoral artery, drug-eluting
ApplicantBoston Scientific Corp.
One Scimed Place
Maple Grove, MN 55311
PMA NumberP180011
Supplement NumberS009
Date Received06/27/2019
Decision Date07/25/2019
Product Code NIU 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Replacement of the current software with new software to collect and process manufacturing test data, and track and trend capability data for various manufacturing areas.
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