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.
Reduction of in-process destructive testing and associated measurements performed on the balloon components of the devices during the balloon molding operation.
| Device | VERIFLEX (LIBERTE) STENT DELIVERY SYSTEM |
| Generic Name | Stent, Coronary |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. |
| Date Received | 2010-08-02 |
| Decision Date | 2010-09-01 |
| PMA | P040016 |
| Supplement | S062 |
| 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 |