Approval for an additional label in the form of a packaging sticker stating, "only use threaded restraints with the ab5000 ventricle. Use of non-threaded cannula restraints may result in: 1) cannulae becoming disconnected from the ventricle, and 2) thrombus formation. "
| Device | ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | ABIOMED CARDIOVASCULAR, INC. |
| Date Received | 2003-12-15 |
| Decision Date | 2003-12-23 |
| PMA | P900023 |
| Supplement | S039 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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