Approval for the addition of a caution statement ''warning: preclot thegraft! " to the package labels for the outflow graft with bend relief (catalog# 102563) andinflow conduit (catalog # 102564). This caution statement is to highlight information currentlyfound in the heartmate ii instructions for use, section 13. 4, which instructs users to pre-clot the two components prior to implantation.
| Device | THORATEC HEARTMATE II LVAS |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | THORATEC CORP. |
| Date Received | 2008-11-20 |
| Decision Date | 2008-12-03 |
| PMA | P060040 |
| Supplement | S002 |
| 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 CORP. 6035 Stoneridge Dr. pleasanton, CA 94588 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P060040 | | Original Filing |
| S089 |
2022-10-31 |
Real-time Process |
| S088 |
2022-10-25 |
30-day Notice |
| S087 |
2022-09-15 |
30-day Notice |
| S086 |
2022-04-18 |
Real-time Process |
| S085 |
2022-03-14 |
30-day Notice |
| S084 | | |
| S083 |
2021-12-16 |
Real-time Process |
| S082 |
2021-12-14 |
Special (immediate Track) |
| S081 |
2021-10-12 |
30-day Notice |
| S080 |
2021-09-10 |
30-day Notice |
| S079 |
2021-02-19 |
30-day Notice |
| S078 |
2020-09-29 |
30-day Notice |
| S077 |
2020-03-16 |
30-day Notice |
| S076 | | |
| S075 |
2019-08-27 |
30-day Notice |
| S074 | | |
| S073 | | |
| S072 |
2019-06-19 |
Normal 180 Day Track No User Fee |
| S071 |
2018-08-29 |
30-day Notice |
| S070 |
2018-05-04 |
30-day Notice |
| S069 |
2017-09-13 |
30-day Notice |
| S068 |
2017-09-08 |
30-day Notice |
| S067 |
2017-07-19 |
30-day Notice |
| S066 |
2017-02-14 |
Real-time Process |
| S065 |
2017-01-04 |
Normal 180 Day Track |
| S064 |
2016-12-07 |
Real-time Process |
| S063 |
2016-11-02 |
30-day Notice |
| S062 |
2016-10-24 |
Real-time Process |
| S061 |
2016-10-20 |
30-day Notice |
| S060 |
2016-07-01 |
Normal 180 Day Track |
| S059 |
2016-05-24 |
Normal 180 Day Track |
| S058 |
2016-04-26 |
135 Review Track For 30-day Notice |
| S057 |
2016-04-22 |
Real-time Process |
| S056 |
2016-04-11 |
Real-time Process |
| S055 |
2016-03-31 |
30-day Notice |
| S054 |
2016-03-28 |
Special (immediate Track) |
| S053 |
2016-02-26 |
30-day Notice |
| S052 |
2016-02-22 |
Real-time Process |
| S051 |
2016-01-28 |
30-day Notice |
| S050 |
2016-01-21 |
Special (immediate Track) |
| S049 |
2015-12-23 |
30-day Notice |
| S048 |
2015-12-11 |
135 Review Track For 30-day Notice |
| S047 |
2015-11-09 |
Real-time Process |
| S046 |
2015-10-08 |
Special (immediate Track) |
| S045 |
2015-10-01 |
30-day Notice |
| S044 |
2015-09-14 |
30-day Notice |
| S043 |
2015-07-21 |
30-day Notice |
| S042 |
2015-05-07 |
30-day Notice |
| S041 |
2015-03-23 |
Real-time Process |
| S040 |
2015-03-04 |
Special (immediate Track) |
| S039 |
2015-02-23 |
30-day Notice |
| S038 |
2015-01-13 |
Special (immediate Track) |
| S037 |
2014-06-23 |
30-day Notice |
| S036 |
2014-05-21 |
Real-time Process |
| S035 |
2014-04-16 |
30-day Notice |
| S034 |
2014-03-24 |
30-day Notice |
| S033 |
2014-03-07 |
Special (immediate Track) |
| S032 |
2014-02-18 |
30-day Notice |
| S031 |
2014-02-10 |
Normal 180 Day Track No User Fee |
| S030 |
2013-09-30 |
Normal 180 Day Track |
| S029 |
2013-07-05 |
30-day Notice |
| S028 |
2013-07-01 |
Real-time Process |
| S027 |
2013-05-06 |
30-day Notice |
| S026 |
2013-03-27 |
Real-time Process |
| S025 |
2013-02-28 |
30-day Notice |
| S024 |
2012-08-08 |
Real-time Process |
| S023 |
2012-06-07 |
Normal 180 Day Track |
| S022 |
2012-05-17 |
Real-time Process |
| S021 |
2012-05-04 |
Real-time Process |
| S020 |
2012-05-03 |
30-day Notice |
| S019 | | |
| S018 |
2012-04-20 |
Normal 180 Day Track |
| S017 |
2012-04-18 |
30-day Notice |
| S016 |
2012-02-28 |
Special (immediate Track) |
| S015 |
2012-02-13 |
Normal 180 Day Track No User Fee |
| S014 |
2010-12-27 |
Normal 180 Day Track No User Fee |
| S013 |
2010-09-17 |
Special (immediate Track) |
| S012 |
2010-08-30 |
Real-time Process |
| S011 |
2010-08-17 |
Normal 180 Day Track No User Fee |
| S010 |
2010-03-08 |
Normal 180 Day Track No User Fee |
| S009 |
2010-04-05 |
Special (immediate Track) |
| S008 |
2010-04-02 |
Normal 180 Day Track |
| S007 |
2010-03-25 |
Real-time Process |
| S006 |
2010-01-25 |
Normal 180 Day Track |
| S005 |
2009-04-20 |
Panel Track |
| S004 |
2008-12-24 |
Normal 180 Day Track |
| S003 |
2008-12-19 |
Special (immediate Track) |
| S002 |
2008-11-20 |
Special (immediate Track) |
| S001 |
2008-07-01 |
Normal 180 Day Track |
NIH GUDID Devices