HeartMate 3™ Left Ventricular Assist System (LVAS)

FDA Premarket Approval P160054 S050

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

DeviceHeartMate 3™ Left Ventricular Assist System (LVAS)
Generic NameVentricular (assist) Bypass
ApplicantAbbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP160054 Supplement NumberS050 Date Received10/31/2022 Decision Date01/10/2023 Product Code DSQ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-10-31
Decision Date2023-01-10
PMAP160054
SupplementS050
Product CodeDSQ 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Medical
6035 Stoneridge Drive
pleasanton, CA 94588 PMA NumberP160054 Supplement NumberS050 Date Received10/31/2022 Decision Date01/10/2023 Product Code DSQ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For A Software Update To The HeartMate Touch Communication (HM Touch) Application Software To Fix Two Anomalies And Add Eleven New Language Translations.

Supplemental Filings

Supplement NumberDateSupplement Type
P160054Original 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 IDPMASupp
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

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