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.
Approval to add an alternate trade name for the libertÉ monorail and over-the-wire coronary stent systems. The device will be marketed under the trade name veriflex bare metal coronary stent and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease with stenotic lesions in native coronary arteries (length
| Device | VERIFLEX FOR LIBERTE BARE METAL STENTS |
| Generic Name | Stent, Coronary |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. |
| Date Received | 2009-09-15 |
| Decision Date | 2009-09-25 |
| PMA | P040016 |
| Supplement | S037 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |