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 two precautions related to the use of overlapping stents and to non-coronary use to the instructions for use.
| Device | CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | CORDIS CORP. |
| Date Received | 2005-12-12 |
| Decision Date | 2006-01-12 |
| PMA | P020026 |
| Supplement | S016 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |