Approval for a labeling update regarding pediatric uses of the device.
| Device | HeartMate 3 Left Ventricular Assist System (HM3 LVAS) |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Thoratec Corporation |
| Date Received | 2020-07-01 |
| Decision Date | 2020-12-17 |
| PMA | P160054 |
| Supplement | S031 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Thoratec Corporation 6035 Stoneridge Drive pleasanton, CA 94588 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160054 | | Original Filing |
| S033 |
2020-12-18 |
30-day Notice |
| S032 |
2020-07-22 |
Real-time Process |
| S031 |
2020-07-01 |
Normal 180 Day Track |
| S030 |
2020-06-08 |
30-day Notice |
| S029 | | |
| S028 |
2020-04-01 |
30-day Notice |
| S027 |
2020-03-24 |
30-day Notice |
| S026 | | |
| S025 | | |
| S024 |
2019-12-03 |
Special (immediate Track) |
| S023 |
2019-08-27 |
30-day Notice |
| S022 | | |
| S021 | | |
| S020 |
2019-07-29 |
30-day Notice |
| S019 |
2019-06-19 |
Normal 180 Day Track No User Fee |
| S018 |
2019-02-19 |
Normal 180 Day Track |
| S017 | | |
| S016 |
2018-12-13 |
Real-time Process |
| S015 |
2018-11-19 |
Normal 180 Day Track No User Fee |
| S014 |
2018-10-29 |
30-day Notice |
| S013 |
2018-09-04 |
Normal 180 Day Track |
| S012 |
2018-08-31 |
Normal 180 Day Track |
| S011 |
2018-08-16 |
Real-time Process |
| S010 |
2018-05-16 |
Special (immediate Track) |
| S009 |
2018-05-04 |
30-day Notice |
| S008 |
2018-05-03 |
Panel Track |
| S007 |
2018-04-16 |
Normal 180 Day Track |
| S006 |
2018-04-12 |
Real-time Process |
| S005 |
2018-03-16 |
Normal 180 Day Track |
| S004 |
2018-03-14 |
135 Review Track For 30-day Notice |
| S003 |
2018-01-08 |
30-day Notice |
| S002 |
2017-09-13 |
30-day Notice |
| S001 |
2017-09-08 |
30-day Notice |
NIH GUDID Devices