THORATEC HEARTMATE II LVAS

Ventricular (assist) Bypass

FDA Premarket Approval P060040 S012

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

Approval for a modification to the heartmate ii patient power cable connectors.

DeviceTHORATEC HEARTMATE II LVAS
Classification NameVentricular (assist) Bypass
Generic NameVentricular (assist) Bypass
ApplicantTHORATEC CORP.
Date Received2010-08-30
Decision Date2010-10-27
PMAP060040
SupplementS012
Product CodeDSQ
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address THORATEC CORP. 6035 Stoneridge Dr. pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P060040Original Filing
S089 2022-10-31 Real-time Process
S088 2022-10-25 30-day Notice
S087 2022-09-15 30-day Notice
S086 2022-04-18 Real-time Process
S085 2022-03-14 30-day Notice
S084
S083 2021-12-16 Real-time Process
S082 2021-12-14 Special (immediate Track)
S081 2021-10-12 30-day Notice
S080 2021-09-10 30-day Notice
S079 2021-02-19 30-day Notice
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
00813024011484 P060040 000
00813024013495 P060040 059
15415067038279 P060040 059
05415067032065 P060040 073
05415067032058 P060040 073
05415067033758 P060040 073

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