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.
Device | COSMOS(TM) SYSTEM |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | BOSTON SCIENTIFIC |
Date Received | 1989-03-16 |
Decision Date | 1989-05-05 |
PMA | P830026 |
Supplement | S038 |
Product Code | LWP |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112 |
Supplement Number | Date | Supplement Type |
---|---|---|
P830026 | Original Filing | |
S083 | 2021-03-08 | 30-day Notice |
S082 | 2013-08-29 | 30-day Notice |
S081 | 2012-11-08 | 30-day Notice |
S080 | 2012-03-24 | 30-day Notice |
S079 | 2004-12-03 | 30-day Notice |
S078 | 2004-10-21 | 30-day Notice |
S077 | 1999-10-25 | Normal 180 Day Track |
S076 | 1999-10-07 | Real-time Process |
S075 | 1999-09-07 | Normal 180 Day Track |
S074 | 1998-10-09 | Normal 180 Day Track |
S073 | 1998-07-01 | Real-time Process |
S072 | ||
S071 | 1998-02-19 | Normal 180 Day Track |
S070 | 1997-03-14 | Normal 180 Day Track |
S069 | 1997-03-06 | Normal 180 Day Track |
S068 | ||
S067 | 1996-03-08 | Normal 180 Day Track |
S066 | 1996-02-01 | Special (immediate Track) |
S065 | 1995-12-12 | Normal 180 Day Track |
S064 | 1995-09-18 | Normal 180 Day Track |
S063 | 1994-12-20 | Normal 180 Day Track |
S062 | 1994-12-05 | Normal 180 Day Track |
S061 | 1994-04-25 | Normal 180 Day Track |
S060 | 1993-11-30 | Normal 180 Day Track |
S059 | 1993-11-04 | Normal 180 Day Track |
S058 | 1993-06-17 | Normal 180 Day Track |
S057 | 1992-08-05 | Normal 180 Day Track |
S056 | 1992-07-24 | Normal 180 Day Track |
S055 | 1992-07-10 | Normal 180 Day Track |
S054 | 1992-05-11 | Normal 180 Day Track |
S053 | 1992-02-12 | Normal 180 Day Track |
S052 | 1991-12-24 | Normal 180 Day Track |
S051 | 1991-12-24 | Normal 180 Day Track |
S050 | ||
S049 | 1991-05-20 | Normal 180 Day Track |
S048 | 1991-05-14 | Normal 180 Day Track |
S047 | 1991-05-10 | Normal 180 Day Track |
S046 | 1991-03-25 | Normal 180 Day Track |
S045 | 1991-03-25 | Normal 180 Day Track |
S044 | 1990-05-08 | Normal 180 Day Track |
S043 | 1990-05-08 | Normal 180 Day Track |
S042 | 1990-05-08 | Normal 180 Day Track |
S041 | 1990-05-08 | Normal 180 Day Track |
S040 | 1990-05-08 | Normal 180 Day Track |
S039 | 1989-09-15 | Normal 180 Day Track |
S038 | 1989-03-16 | Normal 180 Day Track |
S037 | 1988-11-04 | Normal 180 Day Track |
S036 | 1988-08-23 | Normal 180 Day Track |
S035 | 1988-08-09 | Normal 180 Day Track |
S034 | 1988-07-11 | Normal 180 Day Track |
S033 | 1987-09-22 | Normal 180 Day Track |
S032 | 1987-07-01 | Normal 180 Day Track |
S031 | 1987-06-30 | Normal 180 Day Track |
S030 | 1987-06-05 | Normal 180 Day Track |
S029 | 1987-05-12 | Special (immediate Track) |
S028 | 1987-04-13 | Normal 180 Day Track |
S027 | ||
S026 | 1987-03-11 | Normal 180 Day Track |
S025 | 1987-03-04 | Normal 180 Day Track |
S024 | 1987-02-24 | Normal 180 Day Track |
S023 | 1987-01-27 | Normal 180 Day Track |
S022 | 1987-01-15 | Normal 180 Day Track |
S021 | 1986-11-05 | Special (immediate Track) |
S020 | 1986-10-17 | Normal 180 Day Track |
S019 | 1986-09-26 | Special (immediate Track) |
S018 | 1986-07-02 | Normal 180 Day Track |
S017 | 1986-06-02 | Normal 180 Day Track |
S016 | 1986-05-06 | |
S015 | 1986-02-18 | |
S014 | 1985-12-23 | |
S013 | 1985-12-17 | |
S012 | 1985-09-27 | |
S011 | 1985-07-22 | |
S010 | 1985-06-17 | |
S009 | 1985-03-06 | |
S008 | 1985-02-21 | |
S007 | 1985-02-15 | |
S006 | 1985-01-22 | |
S005 | 1984-11-29 | |
S004 | ||
S003 | 1984-10-03 | |
S002 | 1984-08-16 | |
S001 | 1984-07-02 |