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.
Requested a modification in the type of biological indicator used in the sterility release of the carbo-seal aap from the amsco spordex bacillus subtilis globigii spore strips to the 3m healthcare attest bacillus subtilis globigii self-contained biological indicator. The stzated reason for the change is to reduce the incubation period from seven to two days, and to reduce the change of operator error by eliminating the possibilitry of contaimination that may occur when spore strips in glassine envelopes are transferred to growth medium.
Device | SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS |
Classification Name | Heart-valve, Mechanical |
Generic Name | Heart-valve, Mechanical |
Applicant | SORIN GROUP ITALIA S.R.L |
Date Received | 1998-06-01 |
Decision Date | 1998-06-11 |
PMA | P900060 |
Supplement | S017 |
Product Code | LWQ |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
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 |