Approval for design changes to integrate the previously approved 42 fr. Ventricular/atrial cannula and previously approved sewing cuff accessory. The device, as modified, will be marketed under the trade name 42 fr. Ventricular cannula with integrated sewing cuff and is indicated for use with the bvs 5000 biventricular support system and with the ab5000 circulatory support system.
| Device | 42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | ABIOMED CARDIOVASCULAR, INC. |
| Date Received | 2006-01-05 |
| Decision Date | 2006-07-07 |
| PMA | P900023 |
| Supplement | S044 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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