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 for automation of your stent coating process.
| Device | CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | CORDIS CORP. |
| Date Received | 2010-09-28 |
| Decision Date | 2011-03-03 |
| PMA | P020026 |
| Supplement | S081 |
| Product Code | NIQ |
| 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 | 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 |