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.
| Device | Attain StarFix Lead |
| Generic Name | Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode |
| Applicant | MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP060039 Supplement NumberS111 Date Received05/20/2022 Decision Date06/01/2022 Product Code OJX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-20 |
| Decision Date | 2022-06-01 |
| PMA | P060039 |
| Supplement | S111 |
| Product Code | OJX |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112 PMA NumberP060039 Supplement NumberS111 Date Received05/20/2022 Decision Date06/01/2022 Product Code OJX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement to Update The FACTORYWorks Manufacturing Execution System To Release 9.10 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060039 | Original Filing | |
| S112 | 2022-11-16 | 30-day Notice |
| S111 | 2022-05-20 | 30-day Notice |
| S110 | 2022-04-14 | 30-day Notice |
| S109 | 2021-11-18 | 30-day Notice |
| S108 | 2021-08-09 | 30-day Notice |
| S107 | 2021-06-15 | 30-day Notice |
| S106 | 2021-02-05 | 30-day Notice |
| S105 | 2020-12-01 | 30-day Notice |
| S104 | 2020-11-24 | 30-day Notice |
| S103 | 2020-11-13 | 30-day Notice |
| S102 | 2020-10-23 | 30-day Notice |
| S101 | 2020-07-09 | 30-day Notice |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00885074511986 | P060039 | 000 |
| 00885074511962 | P060039 | 000 |
| 00885074511955 | P060039 | 000 |
| 00643169590656 | P060039 | 061 |
| 00643169590649 | P060039 | 061 |
| 00643169590632 | P060039 | 061 |