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 3™ Left Ventricular Assist System (LVAS) |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP160054 Supplement NumberS049 Date Received09/15/2022 Decision Date10/14/2022 Product Code DSQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-15 |
| Decision Date | 2022-10-14 |
| PMA | P160054 |
| Supplement | S049 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 6035 Stoneridge Drive pleasanton, CA 94588 PMA NumberP160054 Supplement NumberS049 Date Received09/15/2022 Decision Date10/14/2022 Product Code DSQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Add An Alternate 2nd Tier Supplier Of Cable Bands |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160054 | Original Filing | |
| S050 | 2022-10-31 | Real-time Process |
| S049 | 2022-09-15 | 30-day Notice |
| S048 | ||
| S047 | 2022-03-14 | 30-day Notice |
| S046 | ||
| S045 | 2021-12-16 | Real-time Process |
| S044 | 2021-12-14 | Special (immediate Track) |
| S043 | 2021-12-09 | 30-day Notice |
| S042 | ||
| S041 | 2021-11-22 | 30-day Notice |
| S040 | 2021-10-12 | 30-day Notice |
| S039 | ||
| S038 | 2021-09-10 | 30-day Notice |
| S037 | 2021-05-12 | 30-day Notice |
| S036 | 2021-03-31 | 30-day Notice |
| S035 | 2021-02-26 | 30-day Notice |
| S034 | 2021-02-19 | 30-day Notice |
| S033 | 2020-12-18 | 30-day Notice |
| S032 | 2020-07-22 | Real-time Process |
| S031 | 2020-07-01 | Normal 180 Day Track |
| S030 | 2020-06-08 | 30-day Notice |
| S029 | ||
| S028 | 2020-04-01 | 30-day Notice |
| S027 | 2020-03-24 | 30-day Notice |
| S026 | ||
| S025 | ||
| S024 | 2019-12-03 | Special (immediate Track) |
| S023 | 2019-08-27 | 30-day Notice |
| S022 | ||
| S021 | ||
| S020 | 2019-07-29 | 30-day Notice |
| S019 | 2019-06-19 | Normal 180 Day Track No User Fee |
| S018 | 2019-02-19 | Normal 180 Day Track |
| S017 | ||
| S016 | 2018-12-13 | Real-time Process |
| S015 | 2018-11-19 | Normal 180 Day Track No User Fee |
| S014 | 2018-10-29 | 30-day Notice |
| S013 | 2018-09-04 | Normal 180 Day Track |
| S012 | 2018-08-31 | Normal 180 Day Track |
| S011 | 2018-08-16 | Real-time Process |
| S010 | 2018-05-16 | Special (immediate Track) |
| S009 | 2018-05-04 | 30-day Notice |
| S008 | 2018-05-03 | Panel Track |
| S007 | 2018-04-16 | Normal 180 Day Track |
| S006 | 2018-04-12 | Real-time Process |
| S005 | 2018-03-16 | Normal 180 Day Track |
| S004 | 2018-03-14 | 135 Review Track For 30-day Notice |
| S003 | 2018-01-08 | 30-day Notice |
| S002 | 2017-09-13 | 30-day Notice |
| S001 | 2017-09-08 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00813024013204 | P160054 | 000 |
| 00813024013082 | P160054 | 005 |
| 05415067038760 | P160054 | 005 |
| 00813024013075 | P160054 | 005 |
| 05415067030801 | P160054 | 006 |
| 05415067039286 | P160054 | 006 |
| 05415067030825 | P160054 | 006 |
| 05415067030818 | P160054 | 006 |
| 05415067039361 | P160054 | 006 |
| 15415067039481 | P160054 | 006 |
| 05415067030368 | P160054 | 007 |
| 00813024013143 | P160054 | 007 |
| 05415067030269 | P160054 | 013 |
| 05415067031105 | P160054 | 016 |
| 05415067041654 | P160054 | 042 |