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