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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 AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP020009
Supplement NumberS012
Date Received10/06/2003
Decision Date10/24/2003
Withdrawal Date12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD A QUALITY CONTROL TEST TO EVALUATE THE ELONGATION PROPERTY OF THE EXTRUDED DISTAL OUTER SHAFT COMPONENT FOR THE EXPRESS2 STENT DELIVERY CATHETER.
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