CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Premarket Approval P020026 S086

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.

Pre-market Approval Supplement Details

Approval of the post-approval study protocol.

DeviceCYPHER SIROLIMUS-ELUTING CORONARY STENT
Generic NameCoronary Drug-eluting Stent
ApplicantCORDIS CORP.
Date Received2012-12-17
Decision Date2014-10-10
PMAP020026
SupplementS086
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555

Supplemental Filings

Supplement NumberDateSupplement Type
P020026Original 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

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