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 sewing cuff modification of the carbomedics(r) prosthetic heart valve. The device, as modified, will be marketed under the trade name sulzer carbomedics orbis(tm) prosthetic heart valve and will be available in the following model numbers and sizes: model 100 (aortic sizes 19, 21, 23, 25, 27, 29, and 31mm), and model 200 (mitral sizes 21, 23, 25, 27, 29, 31, and 33mm).
| Device | SULZER CARBOMEDICS ORBIS PROSTHETIC HEART VALVE |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | SORIN GROUP ITALIA S.R.L |
| Date Received | 1998-09-18 |
| Decision Date | 1999-03-17 |
| PMA | P900060 |
| Supplement | S018 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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 |