Approval for the thoratec heartmate ii lvas. The device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is now also indicated for use in patients with new york heart association (nyha) class iiib or iv end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days, and are not candidates for cardiac transplantation. The heartmate ii lvas is intended for use both inside and outside the hospital, or for transportation of ventricular assist device patients via ground ambulance, fixed-wing aircraft, or helicopter.
| Device | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | THORATEC CORP. |
| Date Received | 2009-04-20 |
| Decision Date | 2010-01-20 |
| Notice Date | 2010-02-22 |
| PMA | P060040 |
| Supplement | S005 |
| Product Code | DSQ |
| Docket Number | 10M-0078 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | THORATEC CORP. 6035 Stoneridge Dr. pleasanton, CA 94588 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P060040 | | Original 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