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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 CORONARY STENT SYSTEM (MONORAIL)
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP020009
Supplement NumberS091
Date Received09/04/2012
Decision Date09/21/2012
Withdrawal Date12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALTERNATE EQUIPMENT FOR DISPENSING AND MIXING URETHANE ADHESIVE.
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