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 use of an alternate conductive epoxy and a production process change for automated application of this epoxy in the manufacture of implantable pulse generators
Device | COSMOS/NOVA/QUANTUM/SUPRIMA/PULSE GENERATORS |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | BOSTON SCIENTIFIC |
Date Received | 1996-03-08 |
Decision Date | 1996-08-19 |
PMA | P830026 |
Supplement | S067 |
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 |