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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 MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP020009
Supplement NumberS067
Date Received10/21/2010
Decision Date11/19/2010
Withdrawal Date12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO PRODUCT FAMILY GROUPING FOR THE PURPOSES OF MICROBIOLOGICAL SAMPLE DESIGNATION AT THE MAPLE GROVE MANUFACTURING FACILITIES FOR PRE-STERILE PRODUCT MONITORING ACTIVITIES.
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