EXPRESS AND EXPRESS 2 CORONARY STENT SYSTEMS

FDA Premarket Approval P020009 S054

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

Modification to a step in the stent final inspection work instruction.

DeviceEXPRESS AND EXPRESS 2 CORONARY STENT SYSTEMS
Generic NameStent, Coronary
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
Date Received2009-11-06
Decision Date2009-12-02
PMAP020009
SupplementS054
Product CodeMAF 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC SCIMED, INC. one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P020009Original Filing
S128 2016-07-21 30-day Notice
S127
S126 2014-09-19 30-day Notice
S125 2014-06-13 Normal 180 Day Track No User Fee
S124 2014-06-02 30-day Notice
S123 2014-04-28 135 Review Track For 30-day Notice
S122 2014-04-07 30-day Notice
S121 2014-03-31 30-day Notice
S120 2014-03-28 30-day Notice
S119 2014-02-25 30-day Notice
S118 2014-02-24 30-day Notice
S117 2014-02-21 30-day Notice
S116 2014-01-15 30-day Notice
S115 2014-01-14 30-day Notice
S114 2013-12-30 30-day Notice
S113 2013-11-26 30-day Notice
S112 2013-11-25 30-day Notice
S111 2013-09-20 30-day Notice
S110 2013-09-19 30-day Notice
S109 2013-08-29 30-day Notice
S108 2013-06-10 30-day Notice
S107 2013-03-25 135 Review Track For 30-day Notice
S106
S105
S104 2013-03-29 Real-time Process
S103
S102 2013-01-16 30-day Notice
S101 2012-11-27 30-day Notice
S100 2012-11-19 30-day Notice
S099 2012-11-16 30-day Notice
S098 2012-11-16 30-day Notice
S097 2012-11-13 30-day Notice
S096 2012-11-02 30-day Notice
S095 2012-10-31 30-day Notice
S094 2012-10-15 30-day Notice
S093 2012-10-11 30-day Notice
S092 2012-09-05 30-day Notice
S091 2012-09-04 30-day Notice
S090 2012-08-03 30-day Notice
S089 2012-07-02 30-day Notice
S088 2012-06-27 135 Review Track For 30-day Notice
S087 2012-06-27 30-day Notice
S086 2012-06-06 30-day Notice
S085 2012-05-02 30-day Notice
S084 2012-04-27 30-day Notice
S083 2012-04-18 30-day Notice
S082 2012-03-23 30-day Notice
S081 2012-02-03 30-day Notice
S080 2011-11-07 30-day Notice
S079 2011-10-14 30-day Notice
S078 2011-09-19 30-day Notice
S077 2011-08-31 30-day Notice
S076 2011-06-27 30-day Notice
S075 2011-06-21 Normal 180 Day Track No User Fee
S074 2011-06-01 30-day Notice
S073 2011-04-01 30-day Notice
S072 2010-12-22 135 Review Track For 30-day Notice
S071 2010-12-22 30-day Notice
S070 2010-12-20 30-day Notice
S069 2010-12-17 30-day Notice
S068 2010-12-14 30-day Notice
S067 2010-10-21 30-day Notice
S066 2010-10-07 135 Review Track For 30-day Notice
S065 2010-06-07 135 Review Track For 30-day Notice
S064 2010-05-24 30-day Notice
S063 2010-04-15 30-day Notice
S062 2010-04-08 135 Review Track For 30-day Notice
S061 2010-03-08 Real-time Process
S060 2010-02-01 30-day Notice
S059 2010-01-28 30-day Notice
S058 2010-01-26 30-day Notice
S057 2009-12-31 30-day Notice
S056 2009-11-10 135 Review Track For 30-day Notice
S055 2009-11-06 30-day Notice
S054 2009-11-06 30-day Notice
S053 2009-11-05 30-day Notice
S052 2009-11-05 30-day Notice
S051 2009-10-30 30-day Notice
S050 2009-08-31 30-day Notice
S049 2009-03-30 30-day Notice
S048 2008-10-30 Real-time Process
S047 2008-10-08 30-day Notice
S046 2008-08-28 30-day Notice
S045 2008-07-02 30-day Notice
S044 2008-05-19 30-day Notice
S043 2008-04-21 30-day Notice
S042 2008-03-31 30-day Notice
S041 2008-01-28 30-day Notice
S040 2007-08-23 135 Review Track For 30-day Notice
S039
S038 2007-03-16 30-day Notice
S037 2007-03-05 30-day Notice
S036 2007-02-13 Real-time Process
S035 2006-12-21 135 Review Track For 30-day Notice
S034 2006-11-30 135 Review Track For 30-day Notice
S033 2006-09-21 135 Review Track For 30-day Notice
S032 2006-09-13 30-day Notice
S031 2006-09-13 30-day Notice
S030 2006-09-07 30-day Notice
S029 2006-09-01 135 Review Track For 30-day Notice
S028 2006-08-31 30-day Notice
S027 2006-05-23 30-day Notice
S026 2006-05-09 30-day Notice
S025 2006-02-06 30-day Notice
S024 2006-02-02 30-day Notice
S023
S022 2005-05-10 30-day Notice
S021 2005-03-14 Normal 180 Day Track No User Fee
S020 2005-02-02 Special (immediate Track)
S019 2005-01-25 Special (immediate Track)
S018 2004-11-05 30-day Notice
S017 2004-10-25 Real-time Process
S016 2004-04-14 30-day Notice
S015 2004-04-05 Special (immediate Track)
S014 2003-12-08 30-day Notice
S013 2003-11-10 30-day Notice
S012 2003-10-06 Special (immediate Track)
S011 2003-10-01 30-day Notice
S010 2003-08-11 30-day Notice
S009 2003-06-27 30-day Notice
S008
S007 2003-02-05 30-day Notice
S006 2003-01-30 Normal 180 Day Track
S005 2002-12-24 Special (immediate Track)
S004 2002-12-23 30-day Notice
S003
S002 2002-10-07 30-day Notice
S001 2002-09-23 30-day Notice

NIH GUDID Devices

Device IDPMASupp
08714729387954 P020009 000
08714729387053 P020009 000
08714729386988 P020009 000
08714729386971 P020009 000
08714729386902 P020009 000
08714729386896 P020009 000
08714729386827 P020009 000
08714729386810 P020009 000
08714729386766 P020009 000
08714729387060 P020009 000
08714729387640 P020009 000
08714729387947 P020009 000
08714729387879 P020009 000
08714729387862 P020009 000
08714729387794 P020009 000
08714729387787 P020009 000
08714729387718 P020009 000
08714729387701 P020009 000
08714729387657 P020009 000
08714729386759 P020009 000

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