Approval for the ab5000 blood pump, used only with the ab5000 console. The device, as modified, will be marketed under the trade name abiomed ab5000 circulatory support system and is indicated for use in patients suffering from reversible ventricular dysfunction. These are patients who have undergone successful cardiac surgery and subsequently develop low cardiac output, or patients who suffer from acute cardiac disorders leading to hemodynamic instability. The intent of ab5000 system therapy is to provide circulatory support, restore normal hemodynamics, reduce ventricular work, and allow the heart time to recover adequate mechanical function. The ab5000 ventricle is external to the patient and is intended for short-term use. Appropriate patient groups include those that are likely to recover cardiac function after the myocardium is permitted to rest on ventricular support. Examples include, but are not limited to: 1) patients who fail to wean from cardiopulmonary bypass following heart surgery. 2) failed transplant patients who require ventricular assist following heart transplantation. 3) patients who require right heart assist (rvad) support while on implantable left ventricular assist device (lvad). 4) patients suffering from acute cardiac disorders such as viral myocarditis. A patient is a candidate for mechanical assistance with the ab5000 system if she/he meets all of the following criteria: a) patient has a body surface area > 1. 3 m(squared) and is
| Device | ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | ABIOMED CARDIOVASCULAR, INC. |
| Date Received | 2003-01-27 |
| Decision Date | 2003-09-24 |
| PMA | P900023 |
| Supplement | S038 |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices