Approval for the attain starfix model 4195 lead. The attain starfix model 4195 steroid eluting, transvenous lead with deployable lobe fixation is intended for chronic pacing and sensing of the left ventricle via the cardiac vein, when used in conjunction with a compatible implantable pulse generator or implantable cardiac defibrillator.
| Device | ATTAIN STARFIX MODEL 4195 LEAD |
| Classification Name | Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode |
| Generic Name | Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2006-12-27 |
| Decision Date | 2008-06-13 |
| Notice Date | 2008-08-27 |
| PMA | P060039 |
| Supplement | S |
| Product Code | OJX |
| Docket Number | 08M-0478 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| 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 |
NIH GUDID Devices