INTEGRITY CORONARY STENT SYSTEMS

Stent, Coronary

FDA Premarket Approval P030009 S048

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

Alternative system for in-process dimensional measurements.

DeviceINTEGRITY CORONARY STENT SYSTEMS
Classification NameStent, Coronary
Generic NameStent, Coronary
ApplicantMEDTRONIC IRELAND
Date Received2010-10-22
Decision Date2010-11-17
PMAP030009
SupplementS048
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
S107 2022-03-23 30-day Notice
S106 2021-10-28 30-day Notice
S105
S104
S103 2021-04-23 Special (immediate Track)
S102 2021-04-12 30-day Notice
S101
S100 2021-03-04 30-day Notice
S099 2021-01-25 30-day Notice
S098 2020-10-26 30-day Notice
S097 2020-07-10 Normal 180 Day Track No User Fee
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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00613994798619 P030009 039
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00613994798633 P030009 039
00613994798640 P030009 039
00613994798879 P030009 039

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