VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

FDA Premarket Approval P040016 S107

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.

Pre-market Approval Supplement Details

Change to the extrusion melt filter.

DeviceVERIFLEX (LIBERTE) CORONARY STENT SYSTEM
Generic NameStent, Coronary
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
Date Received2013-01-16
Decision Date2013-02-14
PMAP040016
SupplementS107
Product CodeMAF 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC SCIMED, INC. one Scimed Place maple Grove, MN 55311

Supplemental Filings

Supplement NumberDateSupplement Type
P040016Original Filing
S134 2014-11-14 135 Review Track For 30-day Notice
S133
S132 2014-09-19 30-day Notice
S131 2014-06-13 Normal 180 Day Track No User Fee
S130
S129 2014-04-28 135 Review Track For 30-day Notice
S128 2014-04-07 30-day Notice
S127 2014-03-31 30-day Notice
S126 2014-03-28 30-day Notice
S125 2014-02-25 30-day Notice
S124 2014-02-24 30-day Notice
S123 2014-02-21 30-day Notice
S122 2014-01-15 30-day Notice
S121 2014-01-14 30-day Notice
S120 2013-12-30 30-day Notice
S119 2013-11-26 30-day Notice
S118 2013-11-25 30-day Notice
S117 2013-09-20 30-day Notice
S116 2013-09-19 30-day Notice
S115 2013-08-29 30-day Notice
S114 2013-06-10 30-day Notice
S113 2013-03-25 135 Review Track For 30-day Notice
S112
S111
S110 2013-03-29 Normal 180 Day Track
S109
S108 2013-01-28 30-day Notice
S107 2013-01-16 30-day Notice
S106 2012-11-27 30-day Notice
S105 2012-11-19 30-day Notice
S104 2012-11-16 30-day Notice
S103 2012-11-16 30-day Notice
S102 2012-11-13 30-day Notice
S101 2012-11-02 30-day Notice
S100 2012-10-31 30-day Notice
S099 2012-10-15 30-day Notice
S098 2012-10-11 30-day Notice
S097 2012-09-05 30-day Notice
S096 2012-09-04 30-day Notice
S095 2012-08-13 30-day Notice
S094 2012-08-03 30-day Notice
S093 2012-07-13 135 Review Track For 30-day Notice
S092 2012-07-02 30-day Notice
S091 2012-06-27 135 Review Track For 30-day Notice
S090 2012-06-27 30-day Notice
S089 2012-06-14 30-day Notice
S088 2012-05-02 30-day Notice
S087 2012-04-27 30-day Notice
S086 2012-04-18 30-day Notice
S085 2012-03-23 30-day Notice
S084 2012-02-03 30-day Notice
S083 2011-12-13 135 Review Track For 30-day Notice
S082 2011-11-07 30-day Notice
S081 2011-10-24 30-day Notice
S080 2011-10-14 30-day Notice
S079 2011-09-30 30-day Notice
S078 2011-09-15 30-day Notice
S077
S076 2011-08-31 30-day Notice
S075 2011-07-05 30-day Notice
S074 2011-06-27 30-day Notice
S073 2011-06-21 Normal 180 Day Track No User Fee
S072 2011-06-01 30-day Notice
S071 2011-04-01 30-day Notice
S070 2011-02-22 30-day Notice
S069 2010-12-22 135 Review Track For 30-day Notice
S068 2010-12-22 30-day Notice
S067 2010-12-20 30-day Notice
S066 2010-12-17 30-day Notice
S065 2010-12-14 30-day Notice
S064 2010-10-21 30-day Notice
S063 2010-10-08 135 Review Track For 30-day Notice
S062 2010-08-02 30-day Notice
S061 2010-07-14 30-day Notice
S060 2010-06-09 30-day Notice
S059 2010-06-07 135 Review Track For 30-day Notice
S058 2010-05-24 30-day Notice
S057 2010-04-16 30-day Notice
S056 2010-04-15 30-day Notice
S055 2010-04-08 135 Review Track For 30-day Notice
S054 2010-03-08 Real-time Process
S053 2010-02-01 30-day Notice
S052 2010-01-26 30-day Notice
S051 2010-01-26 30-day Notice
S050 2010-01-25 30-day Notice
S049 2010-01-19 30-day Notice
S048 2009-12-31 30-day Notice
S047 2009-12-24 135 Review Track For 30-day Notice
S046 2009-12-03 30-day Notice
S045 2009-12-03 30-day Notice
S044 2009-11-10 30-day Notice
S043 2009-11-09 30-day Notice
S042 2009-11-06 30-day Notice
S041 2009-11-06 30-day Notice
S040 2009-11-05 30-day Notice
S039 2009-11-05 30-day Notice
S038 2009-10-30 30-day Notice
S037 2009-09-15 Special (immediate Track)
S036 2009-08-31 30-day Notice
S035 2009-03-30 30-day Notice
S034 2008-10-30 Real-time Process
S033 2008-08-28 30-day Notice
S032 2008-07-02 30-day Notice
S031 2008-05-19 30-day Notice
S030 2008-04-21 30-day Notice
S029 2008-03-31 30-day Notice
S028 2008-01-28 30-day Notice
S027 2007-12-19 30-day Notice
S026 2007-08-23 135 Review Track For 30-day Notice
S025
S024 2007-05-11 30-day Notice
S023 2007-03-16 30-day Notice
S022 2007-02-13 Real-time Process
S021 2006-12-21 135 Review Track For 30-day Notice
S020 2006-12-07 135 Review Track For 30-day Notice
S019 2006-11-30 135 Review Track For 30-day Notice
S018 2006-09-21 135 Review Track For 30-day Notice
S017 2006-09-07 30-day Notice
S016 2006-09-01 135 Review Track For 30-day Notice
S015 2006-08-31 30-day Notice
S014 2006-08-24 30-day Notice
S013 2006-08-24 30-day Notice
S012 2006-06-20 135 Review Track For 30-day Notice
S011 2006-05-23 30-day Notice
S010 2006-05-09 30-day Notice
S009 2006-04-13 30-day Notice
S008 2006-02-06 30-day Notice
S007 2005-11-21 30-day Notice
S006 2005-10-03 30-day Notice
S005 2005-09-22 Normal 180 Day Track No User Fee
S004 2005-09-15 Normal 180 Day Track No User Fee
S003
S002
S001 2005-05-10 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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