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 to revise the ivad instructions for use to delete the reference to paracorporeal placement of the ivad and indicate that the ivad should be contraindicated for the paracorporeal placement.
| Device | THORATEC IMPLANTATION VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | THORATEC LABORATORIES CORP. |
| Date Received | 2007-12-27 |
| Decision Date | 2008-01-31 |
| PMA | P870072 |
| Supplement | S039 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate 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 |