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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP020009
Date Received03/15/2002
Decision Date09/11/2002
Withdrawal Date12/06/2018
Product Code MAF 
Docket Number 03M-0116
Notice Date 03/25/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS. THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE ASSOCIATED WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH < 18 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 TO 5.0 MM. 2) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE (AC/TAC) IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS IN NATIVE CORONARY ARTERIES OF 2.25 TO 5.0 MM (INCLUSIVE) IN DIAMETER AND < 30 MM LONG. LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S074 S075 S076 S071 S072 S089 S090 S040  S073 S082 S077 
S078 S079 S114 S115 S110 S111 S107 S097 S098 S099 S100 S101 
S123 S124 S028 S029 S030 S031 S032 S033 S001 S002 S017 S018 
S019 S020 S021 S015 S016 S045 S046 S009 S010 S011 S012 S013 
S014 S024 S025 S042 S043 S044 S057 S128 S080 S109 S091 S092 
S116 S117 S118 S119 S126 S108 S102 S083 S084 S085 S086 S125 
S093 S094 S095 S096 S112 S113 S120 S121 S122 S081 S087 S088 
S104 S068 S069 S070 S004 S005 S006 S007 S022 S026 S027 S041 
S050 S058 S059 S060 S061 S047 S048 S034 S035 S036 S037 S038 
S062 S063 S051 S052 S053 S054 S055 S056 S066 S067 S049 S064 
S065 
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