Changes to heavy metal testing for silicone.
| Device | Myocardial Pacing Lead |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2017-06-07 |
| Decision Date | 2017-06-22 |
| PMA | P120017 |
| Supplement | S008 |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices