Approval for an alternate method for loading die temperature, heat time, and production line settings for the distal heat shrink process used in manufacturing of the devices at the galway, ireland manufacturing site.
| Device | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM |
| Generic Name | Stent, Coronary |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. |
| Date Received | 2006-12-21 |
| Decision Date | 2007-05-10 |
| PMA | P020009 |
| Supplement | S035 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 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 55311-1566 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P020009 | | Original Filing |
| S128 |
2016-07-21 |
30-day Notice |
| S127 | | |
| S126 |
2014-09-19 |
30-day Notice |
| S125 |
2014-06-13 |
Normal 180 Day Track No User Fee |
| S124 |
2014-06-02 |
30-day Notice |
| S123 |
2014-04-28 |
135 Review Track For 30-day Notice |
| S122 |
2014-04-07 |
30-day Notice |
| S121 |
2014-03-31 |
30-day Notice |
| S120 |
2014-03-28 |
30-day Notice |
| S119 |
2014-02-25 |
30-day Notice |
| S118 |
2014-02-24 |
30-day Notice |
| S117 |
2014-02-21 |
30-day Notice |
| S116 |
2014-01-15 |
30-day Notice |
| S115 |
2014-01-14 |
30-day Notice |
| S114 |
2013-12-30 |
30-day Notice |
| S113 |
2013-11-26 |
30-day Notice |
| S112 |
2013-11-25 |
30-day Notice |
| S111 |
2013-09-20 |
30-day Notice |
| S110 |
2013-09-19 |
30-day Notice |
| S109 |
2013-08-29 |
30-day Notice |
| S108 |
2013-06-10 |
30-day Notice |
| S107 |
2013-03-25 |
135 Review Track For 30-day Notice |
| S106 | | |
| S105 | | |
| S104 |
2013-03-29 |
Real-time Process |
| S103 | | |
| S102 |
2013-01-16 |
30-day Notice |
| S101 |
2012-11-27 |
30-day Notice |
| S100 |
2012-11-19 |
30-day Notice |
| S099 |
2012-11-16 |
30-day Notice |
| S098 |
2012-11-16 |
30-day Notice |
| S097 |
2012-11-13 |
30-day Notice |
| S096 |
2012-11-02 |
30-day Notice |
| S095 |
2012-10-31 |
30-day Notice |
| S094 |
2012-10-15 |
30-day Notice |
| S093 |
2012-10-11 |
30-day Notice |
| S092 |
2012-09-05 |
30-day Notice |
| S091 |
2012-09-04 |
30-day Notice |
| S090 |
2012-08-03 |
30-day Notice |
| S089 |
2012-07-02 |
30-day Notice |
| S088 |
2012-06-27 |
135 Review Track For 30-day Notice |
| S087 |
2012-06-27 |
30-day Notice |
| S086 |
2012-06-06 |
30-day Notice |
| S085 |
2012-05-02 |
30-day Notice |
| S084 |
2012-04-27 |
30-day Notice |
| S083 |
2012-04-18 |
30-day Notice |
| S082 |
2012-03-23 |
30-day Notice |
| S081 |
2012-02-03 |
30-day Notice |
| S080 |
2011-11-07 |
30-day Notice |
| S079 |
2011-10-14 |
30-day Notice |
| S078 |
2011-09-19 |
30-day Notice |
| S077 |
2011-08-31 |
30-day Notice |
| S076 |
2011-06-27 |
30-day Notice |
| S075 |
2011-06-21 |
Normal 180 Day Track No User Fee |
| S074 |
2011-06-01 |
30-day Notice |
| S073 |
2011-04-01 |
30-day Notice |
| S072 |
2010-12-22 |
135 Review Track For 30-day Notice |
| S071 |
2010-12-22 |
30-day Notice |
| S070 |
2010-12-20 |
30-day Notice |
| S069 |
2010-12-17 |
30-day Notice |
| S068 |
2010-12-14 |
30-day Notice |
| S067 |
2010-10-21 |
30-day Notice |
| S066 |
2010-10-07 |
135 Review Track For 30-day Notice |
| S065 |
2010-06-07 |
135 Review Track For 30-day Notice |
| S064 |
2010-05-24 |
30-day Notice |
| S063 |
2010-04-15 |
30-day Notice |
| S062 |
2010-04-08 |
135 Review Track For 30-day Notice |
| S061 |
2010-03-08 |
Real-time Process |
| S060 |
2010-02-01 |
30-day Notice |
| S059 |
2010-01-28 |
30-day Notice |
| S058 |
2010-01-26 |
30-day Notice |
| S057 |
2009-12-31 |
30-day Notice |
| S056 |
2009-11-10 |
135 Review Track For 30-day Notice |
| S055 |
2009-11-06 |
30-day Notice |
| S054 |
2009-11-06 |
30-day Notice |
| S053 |
2009-11-05 |
30-day Notice |
| S052 |
2009-11-05 |
30-day Notice |
| S051 |
2009-10-30 |
30-day Notice |
| S050 |
2009-08-31 |
30-day Notice |
| S049 |
2009-03-30 |
30-day Notice |
| S048 |
2008-10-30 |
Real-time Process |
| S047 |
2008-10-08 |
30-day Notice |
| S046 |
2008-08-28 |
30-day Notice |
| S045 |
2008-07-02 |
30-day Notice |
| S044 |
2008-05-19 |
30-day Notice |
| S043 |
2008-04-21 |
30-day Notice |
| S042 |
2008-03-31 |
30-day Notice |
| S041 |
2008-01-28 |
30-day Notice |
| S040 |
2007-08-23 |
135 Review Track For 30-day Notice |
| S039 | | |
| S038 |
2007-03-16 |
30-day Notice |
| S037 |
2007-03-05 |
30-day Notice |
| S036 |
2007-02-13 |
Real-time Process |
| S035 |
2006-12-21 |
135 Review Track For 30-day Notice |
| S034 |
2006-11-30 |
135 Review Track For 30-day Notice |
| S033 |
2006-09-21 |
135 Review Track For 30-day Notice |
| S032 |
2006-09-13 |
30-day Notice |
| S031 |
2006-09-13 |
30-day Notice |
| S030 |
2006-09-07 |
30-day Notice |
| S029 |
2006-09-01 |
135 Review Track For 30-day Notice |
| S028 |
2006-08-31 |
30-day Notice |
| S027 |
2006-05-23 |
30-day Notice |
| S026 |
2006-05-09 |
30-day Notice |
| S025 |
2006-02-06 |
30-day Notice |
| S024 |
2006-02-02 |
30-day Notice |
| S023 | | |
| S022 |
2005-05-10 |
30-day Notice |
| S021 |
2005-03-14 |
Normal 180 Day Track No User Fee |
| S020 |
2005-02-02 |
Special (immediate Track) |
| S019 |
2005-01-25 |
Special (immediate Track) |
| S018 |
2004-11-05 |
30-day Notice |
| S017 |
2004-10-25 |
Real-time Process |
| S016 |
2004-04-14 |
30-day Notice |
| S015 |
2004-04-05 |
Special (immediate Track) |
| S014 |
2003-12-08 |
30-day Notice |
| S013 |
2003-11-10 |
30-day Notice |
| S012 |
2003-10-06 |
Special (immediate Track) |
| S011 |
2003-10-01 |
30-day Notice |
| S010 |
2003-08-11 |
30-day Notice |
| S009 |
2003-06-27 |
30-day Notice |
| S008 | | |
| S007 |
2003-02-05 |
30-day Notice |
| S006 |
2003-01-30 |
Normal 180 Day Track |
| S005 |
2002-12-24 |
Special (immediate Track) |
| S004 |
2002-12-23 |
30-day Notice |
| S003 | | |
| S002 |
2002-10-07 |
30-day Notice |
| S001 |
2002-09-23 |
30-day Notice |
NIH GUDID Devices