HeartMate 3™ Left Ventricular Assist System

Ventricular (assist) Bypass

FDA Premarket Approval P160054

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the heartmate 3 left ventricular assist system. This device is indicated for providing short-term hemodynamic support (e. G. , bridge to transplant or bridge to myocardial recovery) in patients with advanced refractory left ventricular heart failure.

• Device: HeartMate 3™ Left Ventricular Assist System
• Classification Name: Ventricular (assist) Bypass
• Generic Name: Ventricular (assist) Bypass
• Applicant: Thoratec Corporation
• Date Received: 2016-12-05
• Decision Date: 2017-08-23
• Notice Date: 2017-09-01
• PMA: P160054
• Supplement: S
• Product Code: DSQ
• Docket Number: 17M-5320
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: Thoratec Corporation 6035 Stoneridge Drive pleasanton, CA 94588
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P160054		Original Filing
S050	2022-10-31	Real-time Process
S049	2022-09-15	30-day Notice
S048
S047	2022-03-14	30-day Notice
S046
S045	2021-12-16	Real-time Process
S044	2021-12-14	Special (immediate Track)
S043	2021-12-09	30-day Notice
S042
S041	2021-11-22	30-day Notice
S040	2021-10-12	30-day Notice
S039
S038	2021-09-10	30-day Notice
S037	2021-05-12	30-day Notice
S036	2021-03-31	30-day Notice
S035	2021-02-26	30-day Notice
S034	2021-02-19	30-day Notice
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

Device ID	PMA	Supp
00813024013204	P160054	000
00813024013082	P160054	005
05415067038760	P160054	005
00813024013075	P160054	005
05415067030801	P160054	006
05415067039286	P160054	006
05415067030825	P160054	006
05415067030818	P160054	006
05415067039361	P160054	006
15415067039481	P160054	006
05415067030368	P160054	007
00813024013143	P160054	007
05415067030269	P160054	013
05415067031105	P160054	016
05415067041654	P160054	042