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.
Approval for a valved graft version of the carbomedics(r) prosthetic heart valve (cphv). The device, as modified, will be marketed under the trade name carbomedics(r) carbo-seal(tm) ascending aortic prosthesis (aap) and is indicated for use in open heart surgery for simultaneous replacement of the ascending aorta and the aortic valve in cases of aneurysm, dissection, or other disease conditions of hte aorta combined with disease or degeneration of the aortic valve. The device is available in the sizes of 21, 23, 25, 27, 29, 31, and 33 mm.
| Device | CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | SORIN GROUP ITALIA S.R.L |
| Date Received | 1996-02-08 |
| Decision Date | 1997-03-07 |
| PMA | P900060 |
| Supplement | S012 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SORIN GROUP ITALIA S.R.L via Crescentino, Sn saluggia, Vc 13040 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900060 | Original Filing | |
| S064 | 2022-02-07 | 30-day Notice |
| S063 | 2021-08-10 | Special (immediate Track) |
| S062 | ||
| S061 | 2020-07-09 | 135 Review Track For 30-day Notice |
| S060 | 2019-07-01 | 30-day Notice |
| S059 | 2018-07-10 | 30-day Notice |
| S058 | 2018-06-15 | 30-day Notice |
| S057 | 2018-04-30 | 30-day Notice |
| S056 | 2017-02-10 | 30-day Notice |
| S055 | ||
| S054 | 2015-08-10 | 30-day Notice |
| S053 | 2014-01-23 | 30-day Notice |
| S052 | 2013-06-25 | 30-day Notice |
| S051 | 2012-05-23 | 30-day Notice |
| S050 | 2012-05-23 | 135 Review Track For 30-day Notice |
| S049 | 2012-03-27 | 135 Review Track For 30-day Notice |
| S048 | 2012-02-07 | 30-day Notice |
| S047 | 2011-10-31 | 30-day Notice |
| S046 | 2011-08-05 | 30-day Notice |
| S045 | 2011-06-14 | 30-day Notice |
| S044 | 2011-06-02 | 30-day Notice |
| S043 | 2011-06-02 | 30-day Notice |
| S042 | 2011-06-02 | 30-day Notice |
| S041 | 2011-02-28 | Real-time Process |
| S040 | 2008-05-02 | 30-day Notice |
| S039 | 2007-06-19 | Normal 180 Day Track No User Fee |
| S038 | 2007-03-27 | 30-day Notice |
| S037 | 2006-10-10 | Normal 180 Day Track No User Fee |
| S036 | 2006-01-10 | 30-day Notice |
| S035 | 2005-12-16 | 30-day Notice |
| S034 | 2005-09-06 | 135 Review Track For 30-day Notice |
| S033 | 2005-05-26 | Normal 180 Day Track No User Fee |
| S032 | 2005-05-17 | Normal 180 Day Track No User Fee |
| S031 | ||
| S030 | 2005-01-27 | 135 Review Track For 30-day Notice |
| S029 | 2004-06-14 | 30-day Notice |
| S028 | ||
| S027 | 2003-08-22 | 30-day Notice |
| S026 | 2003-06-27 | 30-day Notice |
| S025 | 2003-05-13 | Real-time Process |
| S024 | 2002-06-11 | Normal 180 Day Track |
| S023 | 2002-02-26 | Normal 180 Day Track |
| S022 | 2001-01-22 | 30-day Notice |
| S021 | 2000-08-07 | 30-day Notice |
| S020 | 1999-07-21 | Normal 180 Day Track |
| S019 | 1999-05-14 | Real-time Process |
| S018 | 1998-09-18 | Real-time Process |
| S017 | 1998-06-01 | 30-day Notice |
| S016 | ||
| S015 | ||
| S014 | 1997-05-07 | Normal 180 Day Track |
| S013 | 1996-02-27 | Normal 180 Day Track |
| S012 | 1996-02-08 | Normal 180 Day Track |
| S011 | 1995-05-17 | Normal 180 Day Track |
| S010 | 1995-02-27 | Normal 180 Day Track |
| S009 | 1995-01-19 | Normal 180 Day Track |
| S008 | ||
| S007 | 1994-12-20 | Normal 180 Day Track |
| S006 | 1994-08-30 | Normal 180 Day Track |
| S005 | 1994-04-23 | Special (immediate Track) |
| S004 | 1994-03-22 | Normal 180 Day Track |
| S003 | 1994-03-01 | Normal 180 Day Track |
| S002 | 1993-12-01 | Normal 180 Day Track |
| S001 | 1993-10-15 | Normal 180 Day Track |