This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | ABIOMED CARDIOVASCULAR, INC. |
| Date Received | 1990-04-06 |
| Decision Date | 1992-11-20 |
| Notice Date | 1993-07-02 |
| PMA | P900023 |
| Supplement | S |
| Product Code | DSQ |
| Docket Number | 92M-0477 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABIOMED CARDIOVASCULAR, INC. 22 Cherry Hill Drive danvers, MA 01923 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900023 | Original Filing | |
| S052 | 2011-10-06 | Normal 180 Day Track |
| S051 | 2009-04-07 | Real-time Process |
| S050 | 2008-08-19 | 30-day Notice |
| S049 | 2008-08-01 | Normal 180 Day Track |
| S048 | 2007-04-23 | Normal 180 Day Track |
| S047 | 2006-11-13 | Normal 180 Day Track |
| S046 | 2006-10-26 | Real-time Process |
| S045 | ||
| S044 | 2006-01-05 | Real-time Process |
| S043 | 2005-01-18 | Real-time Process |
| S042 | 2004-12-22 | Real-time Process |
| S041 | 2004-03-26 | Real-time Process |
| S040 | 2004-03-16 | Real-time Process |
| S039 | 2003-12-15 | Special (immediate Track) |
| S038 | 2003-01-27 | Normal 180 Day Track |
| S037 | 2002-07-01 | Normal 180 Day Track |
| S036 | ||
| S035 | 2001-02-26 | Normal 180 Day Track |
| S034 | 2000-11-15 | Normal 180 Day Track |
| S033 | 2000-05-10 | Normal 180 Day Track |
| S032 | 2000-03-13 | Special (immediate Track) |
| S031 | 1999-10-21 | Normal 180 Day Track |
| S030 | 1999-10-07 | Normal 180 Day Track |
| S029 | 1999-04-02 | Special (immediate Track) |
| S028 | 1999-04-02 | Normal 180 Day Track |
| S027 | 1998-04-02 | Real-time Process |
| S026 | 1998-01-02 | Real-time Process |
| S025 | 1997-11-24 | Normal 180 Day Track |
| S024 | 1997-08-11 | Normal 180 Day Track |
| S023 | 1997-06-19 | Normal 180 Day Track |
| S022 | 1997-03-31 | Normal 180 Day Track |
| S021 | 1997-03-27 | Real-time Process |
| S020 | 1996-12-06 | Normal 180 Day Track |
| S019 | 1996-04-30 | Normal 180 Day Track |
| S018 | 1996-04-02 | Special (immediate Track) |
| S017 | 1995-10-11 | Special (immediate Track) |
| S016 | 1995-08-16 | Normal 180 Day Track |
| S015 | 1995-04-17 | Normal 180 Day Track |
| S014 | 1994-11-04 | Normal 180 Day Track |
| S013 | 1994-08-31 | Normal 180 Day Track |
| S012 | 1994-08-04 | Normal 180 Day Track |
| S011 | 1994-06-16 | Normal 180 Day Track |
| S010 | 1994-05-18 | Normal 180 Day Track |
| S009 | 1994-04-28 | Normal 180 Day Track |
| S008 | 1993-12-29 | Normal 180 Day Track |
| S007 | 1993-09-30 | Normal 180 Day Track |
| S006 | 1993-07-08 | Normal 180 Day Track |
| S005 | 1993-06-30 | Normal 180 Day Track |
| S004 | 1993-04-08 | Normal 180 Day Track |
| S003 | ||
| S002 | ||
| S001 | 1993-01-06 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00813502010848 | P900023 | 052 |
| 00813502010398 | P900023 | 052 |
| 00813502010381 | P900023 | 052 |
| 00813502010374 | P900023 | 052 |
| 00813502010367 | P900023 | 052 |
| 00813502010350 | P900023 | 052 |
| 00813502010343 | P900023 | 052 |
| 00813502010336 | P900023 | 052 |
| 00813502010329 | P900023 | 052 |
| 00813502010312 | P900023 | 052 |
| 00813502010305 | P900023 | 052 |
| 00813502010299 | P900023 | 052 |
| 00813502010282 | P900023 | 052 |
| 00813502010275 | P900023 | 052 |
| 00813502010268 | P900023 | 052 |
| 00813502010404 | P900023 | 052 |
| 00813502010671 | P900023 | 052 |
| 00813502010688 | P900023 | 052 |
| 00813502010831 | P900023 | 052 |
| 00813502010817 | P900023 | 052 |
| 00813502010800 | P900023 | 052 |
| 00813502010794 | P900023 | 052 |
| 00813502010787 | P900023 | 052 |
| 00813502010770 | P900023 | 052 |
| 00813502010763 | P900023 | 052 |
| 00813502010756 | P900023 | 052 |
| 00813502010749 | P900023 | 052 |
| 00813502010732 | P900023 | 052 |
| 00813502010725 | P900023 | 052 |
| 00813502010718 | P900023 | 052 |
| 00813502010701 | P900023 | 052 |
| 00813502010695 | P900023 | 052 |
| 00813502010251 | P900023 | 052 |