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 to add an additional sterilization protocol to the cphv instrumentation instructions for use
| Device | CARBOMEDICS(R) PROSTHETIC HEART VALVE (CPHV) |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | SORIN GROUP ITALIA S.R.L |
| Date Received | 1994-12-20 |
| Decision Date | 1995-10-26 |
| PMA | P900060 |
| Supplement | S007 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |