Approval for the ipulse circulatory support system, a unit that will support patients in need of full circulatory support using the bvs 5000 blood pump or the ab5000 ventricle, or partial ventricular assist using the approved intra-aortic balloon pump (iabp). The device console, as modified, will be marketed under the trade name ipulse circulatory support system and is indicated for use in conjunction with the abiomed ab 5000 ventricle and the bvs 5000 blood pump.
| Device | IPULSE CIRCULATORY SUPPORT SYSTEM |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | ABIOMED CARDIOVASCULAR, INC. |
| Date Received | 2006-11-13 |
| Decision Date | 2007-12-11 |
| PMA | P900023 |
| Supplement | S047 |
| 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