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 | AID(R) B/BR |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1990-09-26 |
| Decision Date | 1991-02-08 |
| PMA | P830060 |
| Supplement | S022 |
| Product Code | LWS |
| 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 |
|---|---|---|
| P830060 | Original Filing | |
| S088 | 2022-11-01 | 30-day Notice |
| S087 | 2021-09-30 | 30-day Notice |
| S086 | 2021-04-30 | 30-day Notice |
| S085 | 2021-03-08 | 30-day Notice |
| S084 | 2021-02-24 | Normal 180 Day Track No User Fee |
| S083 | 2019-03-13 | 30-day Notice |
| S082 | 2018-03-26 | 30-day Notice |
| S081 | 2016-05-27 | 30-day Notice |
| S080 | 2014-06-30 | 30-day Notice |
| S079 | 2014-04-22 | 30-day Notice |
| S078 | 2014-03-04 | Real-time Process |
| S077 | 2014-02-21 | Real-time Process |
| S076 | 2013-08-29 | 30-day Notice |
| S075 | 2013-05-16 | Real-time Process |
| S074 | 2012-11-08 | 30-day Notice |
| S073 | 2012-10-10 | 30-day Notice |
| S072 | 2012-07-26 | Real-time Process |
| S071 | ||
| S070 | 2012-03-26 | 30-day Notice |
| S069 | 2011-05-25 | 30-day Notice |
| S068 | 2011-04-01 | 30-day Notice |
| S067 | 2011-03-28 | Real-time Process |
| S066 | ||
| S065 | 2009-12-18 | 30-day Notice |
| S064 | 2009-12-16 | 30-day Notice |
| S063 | ||
| S062 | 2009-02-24 | Normal 180 Day Track |
| S061 | ||
| S060 | 2006-04-13 | 30-day Notice |
| S059 | 2006-04-13 | 30-day Notice |
| S058 | 2005-05-27 | Special (immediate Track) |
| S057 | 2004-12-03 | 30-day Notice |
| S056 | 2004-10-21 | 30-day Notice |
| S055 | 2004-06-14 | 30-day Notice |
| S054 | 2004-04-14 | 30-day Notice |
| S053 | 2004-01-13 | 30-day Notice |
| S052 | 2003-10-30 | Special (immediate Track) |
| S051 | 2002-11-13 | 30-day Notice |
| S050 | ||
| S049 | 2000-08-21 | Normal 180 Day Track |
| S048 | 2000-04-27 | Real-time Process |
| S047 | 2000-01-11 | Real-time Process |
| S046 | 1999-12-16 | Normal 180 Day Track |
| S045 | 1999-08-25 | Normal 180 Day Track |
| S044 | 1998-11-20 | Real-time Process |
| S043 | 1998-10-13 | Real-time Process |
| S042 | 1996-10-16 | Normal 180 Day Track |
| S041 | 1995-12-21 | Normal 180 Day Track |
| S040 | 1995-02-10 | Normal 180 Day Track |
| S039 | 1995-05-01 | Normal 180 Day Track |
| S038 | 1995-04-06 | Normal 180 Day Track |
| S037 | 1994-12-23 | Normal 180 Day Track |
| S036 | 1994-12-14 | Normal 180 Day Track |
| S035 | 1994-04-20 | Normal 180 Day Track |
| S034 | 1993-10-19 | Normal 180 Day Track |
| S033 | 1993-04-15 | Normal 180 Day Track |
| S032 | 1992-08-26 | Normal 180 Day Track |
| S031 | ||
| S030 | 1992-04-29 | Normal 180 Day Track |
| S029 | 1991-11-22 | Normal 180 Day Track |
| S028 | 1991-11-07 | Normal 180 Day Track |
| S027 | 1991-09-23 | Normal 180 Day Track |
| S026 | 1991-07-05 | Normal 180 Day Track |
| S025 | 1991-05-15 | Normal 180 Day Track |
| S024 | 1990-11-13 | Normal 180 Day Track |
| S023 | 1990-09-27 | Normal 180 Day Track |
| S022 | 1990-09-26 | Normal 180 Day Track |
| S021 | 1990-08-15 | Normal 180 Day Track |
| S020 | 1990-07-23 | Normal 180 Day Track |
| S019 | 1990-05-04 | Normal 180 Day Track |
| S018 | 1990-03-07 | Normal 180 Day Track |
| S017 | ||
| S016 | 1990-03-01 | Normal 180 Day Track |
| S015 | 1990-02-15 | Normal 180 Day Track |
| S014 | 1990-02-15 | Normal 180 Day Track |
| S013 | 1989-11-20 | Normal 180 Day Track |
| S012 | 1989-10-31 | Normal 180 Day Track |
| S011 | 1989-10-17 | Normal 180 Day Track |
| S010 | 1989-10-12 | Normal 180 Day Track |
| S009 | ||
| S008 | 1989-06-13 | Normal 180 Day Track |
| S007 | 1988-08-15 | Normal 180 Day Track |
| S006 | 1988-03-08 | Normal 180 Day Track |
| S005 | 1987-09-22 | Normal 180 Day Track |
| S004 | 1986-09-16 | Normal 180 Day Track |
| S003 | 1986-08-06 | Special (immediate Track) |
| S002 | 1986-02-03 | |
| S001 | 1985-12-03 |
| Device ID | PMA | Supp |
|---|---|---|
| 00802526489303 | P830060 | 000 |
| 00802526067310 | P830060 | 000 |
| 00802526489600 | P830060 | 000 |
| 00802526489563 | P830060 | 000 |
| 00802526489280 | P830060 | 000 |
| 00802526489594 | P830060 | 023 |
| 00802526489587 | P830060 | 023 |
| 00802526489730 | P830060 | 045 |
| 00802526489723 | P830060 | 045 |
| 00802526067518 | P830060 | 067 |
| 00802526064395 | P830060 | 077 |
| 00802526617300 | P830060 | 084 |