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 introduction of labeling addressing compatibility of pacemakers with cellular telephones. Specifically, the following models are affected:cosmos ii 284-05/283-03 -- nova ii 282-04/281-05/281-05s/282-04r/282-04y -- quantum ii 254-30/253-25 -- nova iii 282-09/282-09r/282-07/281/07 -- quantum iii 254-27 -- suprima iii 254-31
Device | RX5000(TM) PROGRAMMER |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | BOSTON SCIENTIFIC |
Date Received | 1996-02-01 |
Decision Date | 1996-03-22 |
PMA | P830026 |
Supplement | S066 |
Product Code | LWP |
Advisory Committee | Cardiovascular |
Supplement Type | Special (immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
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 |