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.
Approval for the use of the vad system in the home environment and for the addition of two accessories for the thoratec vad system: the mobile computer and the car power adapter. The device, as modified, will be marketed under the trade name thoratec paracorporeal ventricular assist device system and tlc-ii portable vad driver. The pvad is indicated for use in bridge to transplant patients who meet all of the following criteria: candidate for cardiac transplantation, imminent risk of dying before donor heart procurement, dependence on, or incomplete response to, continued vasopressor support. It is also indicated for post cardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass. The tlc-ii portable pneumatic driver is intended for use both inside and outside the hospital or for transportation of vad patients via ground ambulance.
| Device | THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | THORATEC LABORATORIES CORP. |
| Date Received | 2002-12-03 |
| Decision Date | 2003-11-20 |
| PMA | P870072 |
| Supplement | S023 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | THORATEC LABORATORIES CORP. 2023 Eighth St. berkeley, CA 94710 |
| 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 |