Integrity RX Coronary Stent System and Integrity OTW Coronary Stent System

FDA Premarket Approval P030009 S096

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

Introduction of an upgraded pouch sealer to the manufacturing process

DeviceIntegrity RX Coronary Stent System and Integrity OTW Coronary Stent System
Generic NameStent, Coronary
ApplicantMEDTRONIC IRELAND
Date Received2020-05-04
Decision Date2020-06-02
PMAP030009
SupplementS096
Product CodeMAF 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC IRELAND parkmore Business Park West galway 

Supplemental Filings

Supplement NumberDateSupplement Type
P030009Original Filing
S096 2020-05-04 30-day Notice
S095 2018-09-24 30-day Notice
S094 2018-09-24 30-day Notice
S093 2017-11-20 30-day Notice
S092 2017-07-03 Real-time Process
S091 2017-01-30 30-day Notice
S090 2016-09-02 30-day Notice
S089 2016-08-17 135 Review Track For 30-day Notice
S088 2016-07-13 30-day Notice
S087 2016-05-16 30-day Notice
S086 2016-04-22 135 Review Track For 30-day Notice
S085 2016-03-14 30-day Notice
S084
S083 2016-01-29 30-day Notice
S082 2015-08-17 30-day Notice
S081 2015-05-14 30-day Notice
S080 2015-03-20 135 Review Track For 30-day Notice
S079 2014-07-02 30-day Notice
S078 2014-04-25 30-day Notice
S077 2014-04-03 30-day Notice
S076 2014-03-18 30-day Notice
S075 2014-02-18 30-day Notice
S074 2014-02-03 Special (immediate Track)
S073 2013-12-16 30-day Notice
S072 2013-11-22 30-day Notice
S071 2013-11-18 30-day Notice
S070 2013-11-15 30-day Notice
S069 2013-09-26 30-day Notice
S068 2013-09-26 30-day Notice
S067 2013-08-19 30-day Notice
S066 2013-08-02 30-day Notice
S065 2013-07-01 30-day Notice
S064 2013-04-08 30-day Notice
S063 2013-03-14 Special (immediate Track)
S062 2012-12-17 30-day Notice
S061 2012-03-22 135 Review Track For 30-day Notice
S060 2011-09-26 30-day Notice
S059
S058 2011-08-08 Real-time Process
S057 2011-07-05 30-day Notice
S056 2011-06-29 30-day Notice
S055 2011-04-15 30-day Notice
S054 2011-04-11 Real-time Process
S053 2010-12-20 30-day Notice
S052 2010-12-10 30-day Notice
S051 2010-12-10 135 Review Track For 30-day Notice
S050 2010-11-15 135 Review Track For 30-day Notice
S049 2010-11-01 30-day Notice
S048 2010-10-22 30-day Notice
S047 2010-10-04 30-day Notice
S046 2010-10-01 30-day Notice
S045 2010-10-01 30-day Notice
S044 2010-08-16 30-day Notice
S043 2010-06-04 30-day Notice
S042 2010-03-16 135 Review Track For 30-day Notice
S041 2010-03-16 30-day Notice
S040 2010-03-01 30-day Notice
S039 2010-02-12 Normal 180 Day Track
S038 2009-12-24 135 Review Track For 30-day Notice
S037 2009-11-09 Normal 180 Day Track No User Fee
S036 2009-10-13 30-day Notice
S035 2009-08-28 30-day Notice
S034 2009-03-23 30-day Notice
S033 2009-02-04 30-day Notice
S032 2008-12-22 30-day Notice
S031 2008-12-22 30-day Notice
S030 2008-12-12 30-day Notice
S029 2008-11-17 30-day Notice
S028 2008-11-05 Normal 180 Day Track No User Fee
S027 2008-10-27 30-day Notice
S026 2008-07-16 135 Review Track For 30-day Notice
S025 2008-05-28 135 Review Track For 30-day Notice
S024 2008-05-23 30-day Notice
S023 2008-05-01 Normal 180 Day Track No User Fee
S022 2008-04-21 30-day Notice
S021 2008-03-31 135 Review Track For 30-day Notice
S020 2008-03-31 Normal 180 Day Track
S019 2008-03-24 135 Review Track For 30-day Notice
S018 2008-01-14 30-day Notice
S017
S016 2007-10-09 30-day Notice
S015 2007-08-01 30-day Notice
S014 2007-08-01 30-day Notice
S013 2007-08-01 135 Review Track For 30-day Notice
S012
S011
S010
S009 2007-07-30 30-day Notice
S008 2006-11-27 Special (immediate Track)
S007 2006-10-30 30-day Notice
S006
S005 2006-07-18 30-day Notice
S004 2005-11-30 30-day Notice
S003 2005-08-29 Real-time Process
S002 2004-07-14 Normal 180 Day Track
S001 2004-02-05 Real-time Process

NIH GUDID Devices

Device IDPMASupp
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00613994602275 P030009 039

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