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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 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP020009
Supplement NumberS017
Date Received10/25/2004
Decision Date03/09/2005
Withdrawal Date12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO LABELING CONTAINED IN THE WARNINGS/ PRECAUTIONS SECTIONS OF THE DIRECTIONS FOR USE (DFU) AND PATIENT GUIDES BASED UPON UPDATED SAFETY INFORMATION RELATED TO MAGNETIC RESONANCE IMAGING (MRI) PERFORMED AT 3 TESLA.
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