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Device | EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P020009 |
Date Received | 03/15/2002 |
Decision Date | 09/11/2002 |
Withdrawal Date
|
12/06/2018 |
Product Code |
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
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Supplements: |
S107 S074 S075 S076 S077 S078 S079 S089 S090 S071 S072 S114 S115 S116 S083 S084 S085 S086 S087 S088 S080 S123 S097 S098 S099 S100 S101 S024 S025 S057 S001 S002 S015 S016 S045 S046 S009 S010 S011 S012 S013 S014 S028 S029 S030 S031 S032 S042 S043 S044 S040 S021 S022 S128 S073 S082 S091 S092 S102 S109 S110 S111 S126 S124 S125 S117 S118 S119 S108 S112 S113 S093 S094 S095 S096 S081 S104 S120 S121 S122 S068 S069 S070 S004 S005 S006 S007 S026 S027 S041 S033 S050 S058 S059 S060 S061 S047 S048 S017 S018 S019 S020 S062 S063 S051 S052 S053 S054 S055 S056 S066 S067 S034 S035 S036 S037 S038 S049 S064 S065 |