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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.
 
DeviceBOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
Generic NameSTENT, CAROTID
ApplicantBoston Scientific Corp.
Three Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP050019
Supplement NumberS004
Date Received02/01/2010
Decision Date07/28/2010
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REPLACING THE PARTIALLY ENCAPSULATED RADIOPAQUE MARKERBAND ON THE DISTAL END OF THE RETRACTABLE OUTER SHEATH IN THE STENT DELIVERY SYSTEM WITH A FULLY ENCAPSULATED RADIOPAQUE MARKERBAND.
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