Transfer an intermediate manufacturing step to fill dexamethasone sodium phosphate and dexamethasone acetate into vials from medtronic energy and component center to the medtronic cardiac rhythm heart failure rice creek pharma manufacturing operations facility and to implement minor process improvements.
| Device | CapSure Epicardial Pacing Lead |
| Classification Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2018-11-21 |
| Decision Date | 2018-12-17 |
| PMA | P950024 |
| Supplement | S083 |
| Product Code | NVN |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P950024 | | Original Filing |
| S105 |
2022-11-16 |
30-day Notice |
| S104 |
2022-05-20 |
30-day Notice |
| S103 |
2022-04-14 |
30-day Notice |
| S102 |
2022-01-13 |
30-day Notice |
| S101 |
2021-11-18 |
30-day Notice |
| S100 |
2021-10-05 |
30-day Notice |
| S099 |
2021-08-09 |
30-day Notice |
| S098 |
2021-02-05 |
30-day Notice |
| S097 |
2020-12-01 |
30-day Notice |
| S096 | | |
| S095 |
2020-10-23 |
30-day Notice |
| S094 |
2020-07-09 |
30-day Notice |
| S093 |
2020-06-26 |
30-day Notice |
| S092 |
2020-03-23 |
Real-time Process |
| S091 |
2020-02-20 |
30-day Notice |
| S090 |
2019-11-18 |
30-day Notice |
| S089 | | |
| S088 |
2019-09-16 |
30-day Notice |
| S087 |
2019-07-01 |
30-day Notice |
| S086 |
2019-06-21 |
30-day Notice |
| S085 |
2019-06-10 |
30-day Notice |
| S084 |
2019-02-28 |
30-day Notice |
| S083 |
2018-11-21 |
30-day Notice |
| S082 |
2018-10-23 |
30-day Notice |
| S081 |
2018-10-18 |
30-day Notice |
| S080 |
2018-09-26 |
30-day Notice |
| S079 |
2018-05-15 |
30-day Notice |
| S078 |
2018-02-22 |
30-day Notice |
| S077 |
2017-11-20 |
30-day Notice |
| S076 |
2017-10-20 |
30-day Notice |
| S075 |
2017-08-07 |
30-day Notice |
| S074 |
2017-06-28 |
30-day Notice |
| S073 |
2017-06-07 |
30-day Notice |
| S072 |
2017-01-17 |
30-day Notice |
| S071 |
2016-11-28 |
30-day Notice |
| S070 |
2016-11-14 |
30-day Notice |
| S069 |
2016-10-05 |
30-day Notice |
| S068 |
2016-06-24 |
30-day Notice |
| S067 |
2015-12-28 |
30-day Notice |
| S066 |
2015-12-22 |
30-day Notice |
| S065 |
2015-09-10 |
30-day Notice |
| S064 |
2015-04-17 |
30-day Notice |
| S063 |
2014-08-27 |
30-day Notice |
| S062 |
2014-08-13 |
30-day Notice |
| S061 |
2014-07-24 |
30-day Notice |
| S060 |
2014-07-14 |
30-day Notice |
| S059 |
2014-02-27 |
30-day Notice |
| S058 |
2014-01-29 |
30-day Notice |
| S057 |
2013-12-24 |
30-day Notice |
| S056 |
2013-12-19 |
30-day Notice |
| S055 |
2013-11-27 |
30-day Notice |
| S054 |
2013-10-30 |
30-day Notice |
| S053 |
2013-10-24 |
30-day Notice |
| S052 |
2013-09-30 |
30-day Notice |
| S051 |
2013-09-17 |
30-day Notice |
| S050 |
2013-05-17 |
Real-time Process |
| S049 |
2013-04-30 |
30-day Notice |
| S048 |
2013-04-10 |
Normal 180 Day Track No User Fee |
| S047 |
2013-03-22 |
30-day Notice |
| S046 |
2012-11-21 |
30-day Notice |
| S045 |
2012-09-28 |
30-day Notice |
| S044 |
2012-09-14 |
Normal 180 Day Track No User Fee |
| S043 |
2012-09-04 |
30-day Notice |
| S042 |
2012-08-03 |
30-day Notice |
| S041 |
2012-02-29 |
30-day Notice |
| S040 |
2011-12-09 |
Normal 180 Day Track No User Fee |
| S039 |
2011-11-25 |
30-day Notice |
| S038 |
2011-11-21 |
Normal 180 Day Track |
| S037 |
2011-10-24 |
135 Review Track For 30-day Notice |
| S036 |
2011-08-17 |
30-day Notice |
| S035 |
2011-07-18 |
30-day Notice |
| S034 |
2011-07-08 |
30-day Notice |
| S033 |
2011-06-28 |
30-day Notice |
| S032 |
2011-06-08 |
30-day Notice |
| S031 |
2011-04-26 |
30-day Notice |
| S030 |
2011-04-12 |
30-day Notice |
| S029 |
2011-03-22 |
135 Review Track For 30-day Notice |
| S028 |
2011-02-28 |
30-day Notice |
| S027 |
2010-11-12 |
30-day Notice |
| S026 |
2010-10-26 |
30-day Notice |
| S025 | | |
| S024 |
2010-07-15 |
30-day Notice |
| S023 |
2010-07-15 |
30-day Notice |
| S022 |
2010-07-15 |
30-day Notice |
| S021 |
2010-06-28 |
135 Review Track For 30-day Notice |
| S020 |
2010-03-29 |
30-day Notice |
| S019 |
2010-01-19 |
30-day Notice |
| S018 |
2010-01-15 |
Real-time Process |
| S017 |
2009-02-25 |
Normal 180 Day Track No User Fee |
| S016 |
2009-02-05 |
30-day Notice |
| S015 |
2008-12-11 |
30-day Notice |
| S014 | | |
| S013 |
2008-11-03 |
30-day Notice |
| S012 | | |
| S011 |
2008-06-17 |
30-day Notice |
| S010 |
2008-04-14 |
30-day Notice |
| S009 |
2008-03-10 |
135 Review Track For 30-day Notice |
| S008 |
2006-05-10 |
135 Review Track For 30-day Notice |
| S007 |
2005-12-30 |
Normal 180 Day Track No User Fee |
| S006 |
2002-12-24 |
Real-time Process |
| S005 |
2001-11-05 |
Special (immediate Track) |
| S004 |
2001-07-17 |
30-day Notice |
| S003 |
1998-07-27 |
Normal 180 Day Track |
| S002 |
1998-07-01 |
Normal 180 Day Track |
| S001 |
1998-04-20 |
Normal 180 Day Track |
NIH GUDID Devices