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 | CapSure Epicardial Pacing Lead |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP950024 Supplement NumberS105 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-16 |
| Decision Date | 2022-11-22 |
| PMA | P950024 |
| Supplement | S105 |
| 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 PMA NumberP950024 Supplement NumberS105 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement relocation Of The “Chemical Operations” Area Within The Same Manufacturing Facility (Medtronic Energy And Component Center) For Selected Components. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00681490116336 | P950024 | 000 |
| 00681490116503 | P950024 | 000 |
| 00681490116725 | P950024 | 002 |
| 00613994492272 | P950024 | 017 |
| 00613994492302 | P950024 | 017 |
| 00613994492340 | P950024 | 017 |
| 00613994501721 | P950024 | 017 |
| 00613994501745 | P950024 | 017 |
| 00613994501776 | P950024 | 017 |
| 00613994501813 | P950024 | 017 |