CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT

FDA Premarket Approval P020026 S083

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 for updated magnetic resonance imaging (mri) compatibility testing and mri conditions of use labeling.

DeviceCYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT
Generic NameCoronary Drug-eluting Stent
ApplicantCORDIS CORP.
Date Received2011-03-21
Decision Date2011-05-27
PMAP020026
SupplementS083
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
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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