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 | ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | ABIOMED CARDIOVASCULAR, INC. |
| Date Received | 1994-04-28 |
| Decision Date | 1994-11-17 |
| PMA | P900023 |
| Supplement | S009 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |