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.
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
| Device | VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM |
| Generic Name | Stent, Coronary |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. |
| Date Received | 2004-03-26 |
| Decision Date | 2005-04-12 |
| Notice Date | 2005-05-18 |
| PMA | P040016 |
| Supplement | S |
| Product Code | MAF |
| Docket Number | 05M-0192 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC SCIMED, INC. one Scimed Place maple Grove, MN 55311 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040016 | Original 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 |