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 the following pacemakers whcih incorporate the edgeband design: cosmos 3 model 284-09e; cosmos ii model 284-05e; stride model 294-05e; dash model 292-03e; dart model 292-05e; unity model 292-07e; nova iii model 282-07e; and thequantum iii model 254-27e. In addition approval for the use of an alternate packaging of polyethylene terephthalate glycol (petg) for all the edgeband models listed above and the following additional models: the side-lock(tm) implantable pulse generator models 282-07, 254-27, and 254-31, and the nova ii model 281-05 and nova iii model 282-04 pulse generators.
Device | COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | BOSTON SCIENTIFIC |
Date Received | 1998-02-19 |
Decision Date | 1998-05-21 |
PMA | P830026 |
Supplement | S071 |
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 |