Change to product family grouping for the purposes of microbiological sample designation at the maple grove manufacturing facilities for pre-sterile product monitoring activities.
| Device | EXPRESS MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM |
| Generic Name | Stent, Coronary |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. |
| Date Received | 2010-10-21 |
| Decision Date | 2010-11-19 |
| PMA | P020009 |
| Supplement | S067 |
| 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 55311-1566 |
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