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.
| Device | HeartMate II® Left Ventricular Assist System |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS086 Date Received04/18/2022 Decision Date06/23/2022 Product Code DSQ Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-04-18 |
| Decision Date | 2022-06-23 |
| PMA | P060040 |
| Supplement | S086 |
| 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 | Abbott Medical 6035 Stoneridge Drive pleasanton, CA 94588 PMA NumberP060040 Supplement NumberS086 Date Received04/18/2022 Decision Date06/23/2022 Product Code DSQ Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Supplement Requested Approval For An Alternate Drop-in Replacement Battery Cell Within The Battery Stack Sub-assembly. The Information Provided Was Sufficient Provided Additional Information Is Submitted As Outlined In The Conditions Of Approval. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00813024012542 | P060040 | 000 |
| 00813024011484 | P060040 | 000 |
| 00813024010883 | P060040 | 000 |
| 00813024013495 | P060040 | 059 |
| 15415067038279 | P060040 | 059 |
| 05415067032065 | P060040 | 073 |
| 05415067032058 | P060040 | 073 |
| 05415067033758 | P060040 | 073 |