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 | Myocardial Pacing Lead |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP120017 Supplement NumberS031 Date Received05/20/2022 Decision Date06/01/2022 Product Code DTB 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 | P120017 |
| Supplement | S031 |
| 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 PMA NumberP120017 Supplement NumberS031 Date Received05/20/2022 Decision Date06/01/2022 Product Code DTB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Update The FACTORYWorks Manufacturing Execution System To Release 9.10 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120017 | Original Filing | |
| S031 | 2022-05-20 | 30-day Notice |
| S030 | 2022-04-14 | 30-day Notice |
| S029 | 2021-11-18 | 30-day Notice |
| S028 | 2021-08-09 | 30-day Notice |
| S027 | 2021-02-05 | 30-day Notice |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00643169638624 | P120017 | 000 |
| 00643169638617 | P120017 | 000 |
| 00643169638600 | P120017 | 000 |
| 00643169638594 | P120017 | 000 |