This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Intended as a bridge to cardiac transplantation for use in patients suffering from end-stage heart failure. The patient should meet all of the following criteria: 1)candidate for cardiac transplantation, 2) imminent risk of dying before donor heart procurement, and 3) dependence o n, or incomplete response to, continue vasopressor support
| Device | THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | THORATEC LABORATORIES CORP. |
| Date Received | 1987-11-24 |
| Decision Date | 1995-12-20 |
| Notice Date | 1997-04-11 |
| PMA | P870072 |
| Supplement | S |
| Product Code | DSQ |
| Docket Number | 97M-0136 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | THORATEC LABORATORIES CORP. 2023 Eighth St. berkeley, CA 94710 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870072 | Original Filing | |
| S062 | 2016-05-16 | 30-day Notice |
| S061 | 2015-12-23 | 30-day Notice |
| S060 | 2015-05-07 | 30-day Notice |
| S059 | 2014-02-18 | 30-day Notice |
| S058 | 2013-11-26 | 30-day Notice |
| S057 | 2013-11-21 | Special (immediate Track) |
| S056 | 2013-07-05 | 30-day Notice |
| S055 | 2013-07-02 | Normal 180 Day Track |
| S054 | 2013-05-16 | Normal 180 Day Track |
| S053 | 2013-04-22 | Real-time Process |
| S052 | 2013-02-28 | 30-day Notice |
| S051 | 2012-10-31 | 30-day Notice |
| S050 | 2012-10-03 | Normal 180 Day Track |
| S049 | 2012-05-30 | 30-day Notice |
| S048 | 2012-05-21 | 30-day Notice |
| S047 | 2011-02-11 | 30-day Notice |
| S046 | 2010-12-27 | Normal 180 Day Track No User Fee |
| S045 | 2010-09-14 | Real-time Process |
| S044 | 2010-08-18 | Normal 180 Day Track |
| S043 | 2010-02-12 | Real-time Process |
| S042 | 2009-09-04 | Real-time Process |
| S041 | 2009-02-23 | Normal 180 Day Track No User Fee |
| S040 | 2008-04-21 | Real-time Process |
| S039 | 2007-12-27 | Special (immediate Track) |
| S038 | ||
| S037 | 2007-07-30 | Real-time Process |
| S036 | 2007-04-16 | Real-time Process |
| S035 | 2006-09-14 | Normal 180 Day Track |
| S034 | 2006-07-12 | Real-time Process |
| S033 | 2004-12-27 | Normal 180 Day Track No User Fee |
| S032 | ||
| S031 | 2004-10-28 | 30-day Notice |
| S030 | 2004-09-29 | Real-time Process |
| S029 | 2004-02-23 | Normal 180 Day Track No User Fee |
| S028 | 2004-03-03 | Real-time Process |
| S027 | 2004-01-06 | Normal 180 Day Track |
| S026 | 2003-07-03 | Real-time Process |
| S025 | 2003-03-10 | Real-time Process |
| S024 | 2002-12-11 | Special (immediate Track) |
| S023 | 2002-12-03 | Normal 180 Day Track |
| S022 | 2002-09-30 | Special (immediate Track) |
| S021 | 2002-09-06 | Normal 180 Day Track |
| S020 | 2002-08-16 | Normal 180 Day Track |
| S019 | 2002-03-27 | Special (immediate Track) |
| S018 | 2001-10-22 | Normal 180 Day Track |
| S017 | 2001-08-01 | Normal 180 Day Track |
| S016 | 2001-06-29 | Normal 180 Day Track |
| S015 | 2001-06-07 | Normal 180 Day Track |
| S014 | ||
| S013 | 2000-10-30 | Normal 180 Day Track |
| S012 | 2000-09-25 | Normal 180 Day Track |
| S011 | 2000-04-24 | Normal 180 Day Track |
| S010 | 2000-04-11 | Normal 180 Day Track |
| S009 | 1998-11-17 | Normal 180 Day Track |
| S008 | ||
| S007 | 1998-07-13 | 30-day Notice |
| S006 | 1997-12-22 | Normal 180 Day Track |
| S005 | 1997-10-06 | Panel Track |
| S004 | 1997-05-28 | Real-time Process |
| S003 | 1996-10-18 | Normal 180 Day Track |
| S002 | 1996-04-08 | Special (immediate Track) |
| S001 | 1996-01-30 | Normal 180 Day Track |