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.
To update the manufacturing execution system to factoryworks release 9. 8
| Device | Myocardial Pacing Lead |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2020-11-24 |
| Decision Date | 2020-12-15 |
| PMA | P120017 |
| Supplement | S025 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120017 | Original Filing | |
| S026 | 2020-12-01 | 30-day Notice |
| S025 | 2020-11-24 | 30-day Notice |
| S024 | 2020-10-23 | 30-day Notice |
| S023 | 2020-07-09 | 30-day Notice |
| S022 | 2020-06-26 | 30-day Notice |
| S021 | 2020-03-23 | Real-time Process |
| S020 | 2019-11-18 | 30-day Notice |
| S019 | 2019-09-16 | 30-day Notice |
| S018 | 2019-06-10 | 30-day Notice |
| S017 | 2019-02-28 | 30-day Notice |
| S016 | 2018-10-23 | 30-day Notice |
| S015 | 2018-10-18 | 30-day Notice |
| S014 | 2018-09-26 | 30-day Notice |
| S013 | 2018-05-15 | 30-day Notice |
| S012 | 2018-02-22 | 30-day Notice |
| S011 | 2017-11-20 | 30-day Notice |
| S010 | 2017-08-07 | 30-day Notice |
| S009 | 2017-06-28 | 30-day Notice |
| S008 | 2017-06-07 | 30-day Notice |
| S007 | 2016-11-14 | 30-day Notice |
| S006 | 2016-10-05 | 30-day Notice |
| S005 | 2016-08-25 | 30-day Notice |
| S004 | 2016-06-24 | 30-day Notice |
| S003 | 2015-12-28 | 30-day Notice |
| S002 | 2015-12-22 | 30-day Notice |
| S001 | 2015-09-10 | 30-day Notice |