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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.
 
Trade NameVERIFLEX (LIBERTE) BARE-METAL CORONARY STEM SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP040016
Date Received03/26/2004
Decision Date04/12/2005
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 05M-0192
Notice Date 05/18/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the boston scientific corporation liberte monorail and over-the-wire coronary stent systems. The devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease with stenotic lesions in native coronary arteries (length <=28 mm) with a reference vessel diameter of 2. 75 to 5. 00 mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
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S031 S032 S033 S034 S035 S036 S037 S038 S039 
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 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 S103 
S104 S105 S106 S107 S108 S110 S113 S114 S115 
S116 S117 S118 S119 S120 S121 S122 S123 S124 
S125 S126 S127 S128 S130 S132 
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