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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, coronary
Generic Namestent, coronary
one scimed place
maple grove, MN 55311-1566
PMA NumberP020009
Date Received03/15/2002
Decision Date09/11/2002
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 03M-0116
Notice Date 03/25/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S004 S005 S006 S007 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S024 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S040 
S041 S042 S043 S044 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 
S059 S060 S061 S062 S063 S064 S065 S066 S067 
S068 S069 S070 S071 S072 S073 S074 S075 S076 
S077 S078 S079 S080 S081 S082 S083 S084 S085 
S086 S087 S088 S089 S090 S091 S092 S093 S094 
S095 S096 S097 S098 S099 S100 S101 S102 S104 
S107 S108 S109 S110 S111 S112 S113 S114 S115 
S116 S117 S118 S119 S120 S121 S122 S123 S124 
S125 S126 S128