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.
Change to the method that is used to create the proximal marks, three white circumferential markings, located on the shaft of the catheter.
| Device | LIBERTE OTW CORONARY STENT SYSTEM |
| Generic Name | Stent, Coronary |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. |
| Date Received | 2008-08-28 |
| Decision Date | 2008-09-26 |
| PMA | P040016 |
| Supplement | S033 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC SCIMED, INC. one Scimed Place maple Grove, MN 55311 |
| 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 |