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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.
 
DeviceEXPRESS/EXPRESS2 MONORAIL AND OVER-THE-WIRE CONRONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP020009
Supplement NumberS116
Date Received01/15/2014
Decision Date02/06/2014
Withdrawal Date 12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
REPLACEMENT OF A CAMERA IN THE CATHETER INSPECTION PROCESS.
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