HeartMate 3 Left Ventricular Assist System

FDA Premarket Approval P160054 S034

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.

Pre-market Approval Supplement Details

Addition of 5 alternate components from alternate second tier suppliers for the heartmate 3 system controller pcbas, one of which is a shared component with the heartmate ii system controller pcba

DeviceHeartMate 3 Left Ventricular Assist System
Generic NameVentricular (assist) Bypass
ApplicantThoratec Corporation
Date Received2021-02-19
Decision Date2021-03-21
Product CodeDSQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Thoratec Corporation 6035 Stoneridge Drive pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P160054Original Filing
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
S028 2020-04-01 30-day Notice
S027 2020-03-24 30-day Notice
S024 2019-12-03 Special (immediate Track)
S023 2019-08-27 30-day Notice
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
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


Device IDPMASupp
00813024013082 P160054 005
00813024013075 P160054 005
05415067030825 P160054 006
05415067030818 P160054 006
05415067030801 P160054 006
05415067030368 P160054 007
00813024013143 P160054 007
05415067030269 P160054 013
05415067031105 P160054 016

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