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 strengthen the ivad y-connector termination by adding a small amount (35 ul) of silicone oil to the inner wall of the pneumatic line to reduce the transferable force between the ivad optical sensor cable and the pneumatic line wall.
| Device | THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | THORATEC LABORATORIES CORP. |
| Date Received | 2008-04-21 |
| Decision Date | 2008-10-31 |
| PMA | P870072 |
| Supplement | S040 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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 |