Attain StarFix Lead

FDA Premarket Approval P060039 S100

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

For test method updates including technical content changes based on test method validation reports

DeviceAttain StarFix Lead
Generic NameDrug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
ApplicantMEDTRONIC Inc.
Date Received2020-06-26
Decision Date2020-07-22
PMAP060039
SupplementS100
Product CodeOJX 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P060039Original Filing
S100 2020-06-26 30-day Notice
S099 2020-02-20 30-day Notice
S098 2019-11-18 30-day Notice
S097
S096 2019-09-16 30-day Notice
S095 2019-06-20 30-day Notice
S094 2019-06-10 30-day Notice
S093 2019-02-28 30-day Notice
S092 2018-10-23 30-day Notice
S091 2018-10-18 30-day Notice
S090 2018-09-26 30-day Notice
S089 2018-06-20 30-day Notice
S088 2018-06-01 30-day Notice
S087 2018-05-15 30-day Notice
S086 2018-04-09 30-day Notice
S085 2018-03-28 30-day Notice
S084 2018-02-22 30-day Notice
S083 2018-01-26 Normal 180 Day Track No User Fee
S082 2017-11-20 30-day Notice
S081 2017-08-07 30-day Notice
S080 2017-06-27 30-day Notice
S079 2017-06-23 30-day Notice
S078 2017-06-07 30-day Notice
S077 2017-01-17 30-day Notice
S076 2016-11-28 30-day Notice
S075 2016-11-14 30-day Notice
S074 2016-10-05 30-day Notice
S073 2016-09-12 30-day Notice
S072 2016-09-02 30-day Notice
S071 2016-06-24 30-day Notice
S070 2016-06-13 30-day Notice
S069 2015-12-28 30-day Notice
S068 2015-12-22 30-day Notice
S067 2015-04-17 30-day Notice
S066 2015-02-09 30-day Notice
S065 2014-12-03 135 Review Track For 30-day Notice
S064 2014-09-29 30-day Notice
S063 2014-08-27 30-day Notice
S062 2014-08-22 Normal 180 Day Track No User Fee
S061 2014-08-08 30-day Notice
S060 2014-07-24 30-day Notice
S059 2014-06-26 Normal 180 Day Track
S058 2014-03-18 30-day Notice
S057 2014-02-27 30-day Notice
S056 2014-02-07 Normal 180 Day Track No User Fee
S055 2013-12-24 30-day Notice
S054 2013-12-19 30-day Notice
S053 2013-10-30 30-day Notice
S052 2013-10-24 30-day Notice
S051 2013-09-30 30-day Notice
S050 2013-09-17 30-day Notice
S049 2013-09-13 Normal 180 Day Track No User Fee
S048
S047 2013-05-17 Real-time Process
S046 2013-04-30 30-day Notice
S045
S044 2013-04-10 Normal 180 Day Track No User Fee
S043 2013-03-22 30-day Notice
S042 2013-03-20 30-day Notice
S041 2012-12-10 30-day Notice
S040 2012-11-29 30-day Notice
S039 2012-11-21 30-day Notice
S038 2012-09-28 30-day Notice
S037 2012-09-21 30-day Notice
S036 2012-09-04 30-day Notice
S035 2012-08-03 30-day Notice
S034 2012-02-29 30-day Notice
S033 2012-02-22 Normal 180 Day Track No User Fee
S032 2011-11-25 30-day Notice
S031 2011-11-21 Normal 180 Day Track
S030 2011-07-18 30-day Notice
S029 2011-07-08 30-day Notice
S028 2011-06-28 30-day Notice
S027 2011-06-08 30-day Notice
S026 2011-06-08 135 Review Track For 30-day Notice
S025 2011-04-26 30-day Notice
S024 2011-03-22 135 Review Track For 30-day Notice
S023 2011-03-18 135 Review Track For 30-day Notice
S022 2011-02-28 30-day Notice
S021 2011-01-26 Normal 180 Day Track
S020 2010-11-12 30-day Notice
S019 2010-10-26 30-day Notice
S018 2010-10-14 30-day Notice
S017
S016 2010-08-23 Normal 180 Day Track No User Fee
S015 2010-07-15 30-day Notice
S014 2010-07-15 30-day Notice
S013 2010-06-28 135 Review Track For 30-day Notice
S012 2010-06-09 30-day Notice
S011 2010-03-29 30-day Notice
S010 2010-02-19 Normal 180 Day Track No User Fee
S009 2010-01-19 30-day Notice
S008 2009-10-26 Normal 180 Day Track No User Fee
S007 2009-10-08 Real-time Process
S006 2009-08-27 Normal 180 Day Track
S005 2008-12-11 30-day Notice
S004 2008-11-03 30-day Notice
S003 2008-07-21 Normal 180 Day Track
S002 2008-07-14 Normal 180 Day Track No User Fee
S001 2008-07-09 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00885074511955 P060039 000
00885074511962 P060039 000
00885074511986 P060039 000
00885074511955 P060039 000
00885074511962 P060039 000
00885074511986 P060039 000
00643169590632 P060039 061
00643169590649 P060039 061
00643169590656 P060039 061
00643169590632 P060039 061
00643169590649 P060039 061
00643169590656 P060039 061

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