HeartMate II Left Ventricular Assist System (LVAS)

FDA Premarket Approval P060040 S078

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

To add an alternative second tier supplier of a component used to manufacture the sealed inflow graft of the heartmate ii left ventricular assist device

DeviceHeartMate II Left Ventricular Assist System (LVAS)
Generic NameVentricular (assist) Bypass
ApplicantTHORATEC CORP.
Date Received2020-09-29
Decision Date2020-10-27
PMAP060040
SupplementS078
Product CodeDSQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address THORATEC CORP. 6035 Stoneridge Dr. pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P060040Original Filing
S078 2020-09-29 30-day Notice
S077 2020-03-16 30-day Notice
S076
S075 2019-08-27 30-day Notice
S074
S073
S072 2019-06-19 Normal 180 Day Track No User Fee
S071 2018-08-29 30-day Notice
S070 2018-05-04 30-day Notice
S069 2017-09-13 30-day Notice
S068 2017-09-08 30-day Notice
S067 2017-07-19 30-day Notice
S066 2017-02-14 Real-time Process
S065 2017-01-04 Normal 180 Day Track
S064 2016-12-07 Real-time Process
S063 2016-11-02 30-day Notice
S062 2016-10-24 Real-time Process
S061 2016-10-20 30-day Notice
S060 2016-07-01 Normal 180 Day Track
S059 2016-05-24 Normal 180 Day Track
S058 2016-04-26 135 Review Track For 30-day Notice
S057 2016-04-22 Real-time Process
S056 2016-04-11 Real-time Process
S055 2016-03-31 30-day Notice
S054 2016-03-28 Special (immediate Track)
S053 2016-02-26 30-day Notice
S052 2016-02-22 Real-time Process
S051 2016-01-28 30-day Notice
S050 2016-01-21 Special (immediate Track)
S049 2015-12-23 30-day Notice
S048 2015-12-11 135 Review Track For 30-day Notice
S047 2015-11-09 Real-time Process
S046 2015-10-08 Special (immediate Track)
S045 2015-10-01 30-day Notice
S044 2015-09-14 30-day Notice
S043 2015-07-21 30-day Notice
S042 2015-05-07 30-day Notice
S041 2015-03-23 Real-time Process
S040 2015-03-04 Special (immediate Track)
S039 2015-02-23 30-day Notice
S038 2015-01-13 Special (immediate Track)
S037 2014-06-23 30-day Notice
S036 2014-05-21 Real-time Process
S035 2014-04-16 30-day Notice
S034 2014-03-24 30-day Notice
S033 2014-03-07 Special (immediate Track)
S032 2014-02-18 30-day Notice
S031 2014-02-10 Normal 180 Day Track No User Fee
S030 2013-09-30 Normal 180 Day Track
S029 2013-07-05 30-day Notice
S028 2013-07-01 Real-time Process
S027 2013-05-06 30-day Notice
S026 2013-03-27 Real-time Process
S025 2013-02-28 30-day Notice
S024 2012-08-08 Real-time Process
S023 2012-06-07 Normal 180 Day Track
S022 2012-05-17 Real-time Process
S021 2012-05-04 Real-time Process
S020 2012-05-03 30-day Notice
S019
S018 2012-04-20 Normal 180 Day Track
S017 2012-04-18 30-day Notice
S016 2012-02-28 Special (immediate Track)
S015 2012-02-13 Normal 180 Day Track No User Fee
S014 2010-12-27 Normal 180 Day Track No User Fee
S013 2010-09-17 Special (immediate Track)
S012 2010-08-30 Real-time Process
S011 2010-08-17 Normal 180 Day Track No User Fee
S010 2010-03-08 Normal 180 Day Track No User Fee
S009 2010-04-05 Special (immediate Track)
S008 2010-04-02 Normal 180 Day Track
S007 2010-03-25 Real-time Process
S006 2010-01-25 Normal 180 Day Track
S005 2009-04-20 Panel Track
S004 2008-12-24 Normal 180 Day Track
S003 2008-12-19 Special (immediate Track)
S002 2008-11-20 Special (immediate Track)
S001 2008-07-01 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00813024012542 P060040 000
00813024013495 P060040 059
05415067032058 P060040 073
05415067033758 P060040 073
05415067032058 P060040 073
05415067033758 P060040 073
05415067032058 P060040 073
05415067033758 P060040 073
05415067032058 P060040 073
05415067033758 P060040 073
05415067032058 P060040 073
05415067033758 P060040 073
05415067033758 P060040 073
05415067032058 P060040 073
05415067032065 P060040 073
05415067032058 P060040 073
05415067032065 P060040 073
05415067032058 P060040 073
05415067033758 P060040 073
05415067033758 P060040 073
05415067032058 P060040 073
05415067033758 P060040 073
05415067032058 P060040 073
05415067033758 P060040 073
05415067032058 P060040 073

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