This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the cypher sirolimus-eluting coronary stent on the raptor over-the-wire delivery system or raptorrail rapid exchange delivery system. The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length = 2. 5 to
Device | CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER |
Generic Name | Coronary Drug-eluting Stent |
Applicant | CORDIS CORP. |
Date Received | 2002-06-28 |
Decision Date | 2003-04-24 |
Notice Date | 2004-09-08 |
PMA | P020026 |
Supplement | S |
Product Code | NIQ |
Docket Number | 03M-0172 |
Advisory Committee | Cardiovascular |
Expedited Review | Yes |
Combination Product | Yes |
Applicant Address | CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555 |
Summary: | Summary of Safety and Effectiveness |
Labeling: | Labeling Labeling Part 2 |
Post-Approval Study: | Show Report Schedule and Study Progress |
Approval Order: | Approval Order |
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 |