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 addition of the tlc-ii portable pneumatic driver to the thoratec paracorporeal ventricular assist device system. The tlc-ii portable pneumatic driver is intended to be interchangeable with the dual drive console in the (currently approved) thoratec paracorporeal ventricular device system for either bridge to transplant patients or for postcardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass. The tlc-ii portable pneumatic driver is intended for use either in the hospital or in a medically monitored residence facility. In addition, the tlc-ii portable pneumatic driver can be used to allow suitably qualified patients to take off-site excursions within a two-hour travel radius of the hospital in the company of a trained caregiver.
| Device | THORATEC VENTRICULAR ASIST DEVICE |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | THORATEC LABORATORIES CORP. |
| Date Received | 2000-09-25 |
| Decision Date | 2001-06-01 |
| PMA | P870072 |
| Supplement | S012 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |