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.
Inclusion of the cordis llc san german site as an alternate bacterial endotoxin test (bet) testing facility.
| Device | CYPHER SIROLIMUS-ELUTING CORONARY STENTS |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | CORDIS CORP. |
| Date Received | 2008-04-01 |
| Decision Date | 2008-05-01 |
| PMA | P020026 |
| Supplement | S051 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020026 | Original Filing | |
| S086 | 2012-12-17 | Normal 180 Day Track No User Fee |
| S085 | 2011-05-06 | Normal 180 Day Track |
| S084 | ||
| S083 | 2011-03-21 | Real-time Process |
| S082 | 2010-11-15 | Normal 180 Day Track |
| S081 | 2010-09-28 | 135 Review Track For 30-day Notice |
| S080 | 2010-07-06 | 30-day Notice |
| S079 | 2010-04-26 | Normal 180 Day Track No User Fee |
| S078 | 2010-01-11 | 135 Review Track For 30-day Notice |
| S077 | 2009-12-24 | 30-day Notice |
| S076 | ||
| S075 | 2009-12-18 | 30-day Notice |
| S074 | 2009-12-10 | Special (immediate Track) |
| S073 | 2009-12-04 | 135 Review Track For 30-day Notice |
| S072 | 2009-12-04 | 30-day Notice |
| S071 | 2009-10-16 | 135 Review Track For 30-day Notice |
| S070 | 2009-10-01 | 135 Review Track For 30-day Notice |
| S069 | 2009-09-30 | 30-day Notice |
| S068 | 2009-09-10 | 30-day Notice |
| S067 | 2009-09-02 | 30-day Notice |
| S066 | 2009-08-14 | 30-day Notice |
| S065 | ||
| S064 | ||
| S063 | 2009-04-10 | 30-day Notice |
| S062 | ||
| S061 | 2009-04-03 | 135 Review Track For 30-day Notice |
| S060 | 2008-12-19 | 30-day Notice |
| S059 | 2008-12-08 | Normal 180 Day Track |
| S058 | 2008-10-20 | 30-day Notice |
| S057 | 2008-08-12 | 30-day Notice |
| S056 | 2008-07-29 | 30-day Notice |
| S055 | 2008-07-25 | 30-day Notice |
| S054 | ||
| S053 | 2008-06-11 | 30-day Notice |
| S052 | 2008-07-01 | 135 Review Track For 30-day Notice |
| S051 | 2008-04-01 | 30-day Notice |
| S050 | 2008-03-05 | 135 Review Track For 30-day Notice |
| S049 | ||
| S048 | 2007-12-21 | Normal 180 Day Track No User Fee |
| S047 | 2007-11-09 | 30-day Notice |
| S046 | 2007-11-09 | 135 Review Track For 30-day Notice |
| S045 | 2007-11-09 | 30-day Notice |
| S044 | 2007-10-22 | 135 Review Track For 30-day Notice |
| S043 | ||
| S042 | 2007-09-06 | Normal 180 Day Track No User Fee |
| S041 | 2007-08-22 | 30-day Notice |
| S040 | 2007-08-08 | 30-day Notice |
| S039 | 2007-06-19 | 135 Review Track For 30-day Notice |
| S038 | 2007-06-18 | 135 Review Track For 30-day Notice |
| S037 | 2007-06-11 | 30-day Notice |
| S036 | 2007-05-21 | 30-day Notice |
| S035 | 2007-05-21 | 30-day Notice |
| S034 | 2007-04-05 | 30-day Notice |
| S033 | 2007-02-23 | 30-day Notice |
| S032 | 2006-10-31 | Special (immediate Track) |
| S031 | 2006-10-31 | Special (immediate Track) |
| S030 | 2006-10-31 | Normal 180 Day Track |
| S029 | 2006-10-31 | 135 Review Track For 30-day Notice |
| S028 | 2006-10-31 | 30-day Notice |
| S027 | ||
| S026 | 2006-07-25 | Normal 180 Day Track |
| S025 | 2006-07-17 | Normal 180 Day Track No User Fee |
| S024 | ||
| S023 | 2006-05-30 | 135 Review Track For 30-day Notice |
| S022 | 2006-05-30 | 135 Review Track For 30-day Notice |
| S021 | 2006-05-30 | 135 Review Track For 30-day Notice |
| S020 | ||
| S019 | ||
| S018 | 2006-04-07 | Normal 180 Day Track No User Fee |
| S017 | 2006-04-03 | Normal 180 Day Track |
| S016 | 2005-12-12 | Special (immediate Track) |
| S015 | 2005-09-07 | 30-day Notice |
| S014 | 2005-07-18 | Real-time Process |
| S013 | 2005-05-05 | Special (immediate Track) |
| S012 | ||
| S011 | 2004-10-01 | Normal 180 Day Track No User Fee |
| S010 | 2004-01-20 | Real-time Process |
| S009 | ||
| S008 | 2003-12-17 | Real-time Process |
| S007 | ||
| S006 | ||
| S005 | 2003-07-02 | Special (immediate Track) |
| S004 | 2003-06-26 | Real-time Process |
| S003 | 2003-06-23 | Real-time Process |
| S002 | ||
| S001 | 2003-05-01 | Normal 180 Day Track No User Fee |