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.
To implement the global labeling system version 3. 0 at select locations
| Device | COSMOS System |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2021-03-08 |
| Decision Date | 2021-04-02 |
| PMA | P830026 |
| Supplement | S083 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 | 0000-00-00 | |
| S079 | 2004-12-03 | 30-day Notice |
| S078 | ||
| S077 | 0000-00-00 | |
| S076 | 0000-00-00 | |
| S075 | 0000-00-00 | |
| S074 | 0000-00-00 | |
| S073 | 0000-00-00 | |
| S072 | ||
| S071 | 1998-02-19 | Normal 180 Day Track |
| S070 | 0000-00-00 | |
| S069 | 0000-00-00 | |
| S068 | ||
| S067 | 0000-00-00 | |
| S066 | 0000-00-00 | |
| S065 | 0000-00-00 | |
| S064 | 0000-00-00 | |
| S063 | 1994-12-20 | Normal 180 Day Track |
| S062 | 0000-00-00 | |
| S061 | 1994-04-25 | Normal 180 Day Track |
| S060 | 0000-00-00 | |
| S059 | 1993-11-04 | Normal 180 Day Track |
| S058 | 0000-00-00 | |
| S057 | 0000-00-00 | |
| S056 | 0000-00-00 | |
| S055 | 0000-00-00 | |
| S054 | 0000-00-00 | |
| S053 | 0000-00-00 | |
| S052 | 0000-00-00 | |
| S051 | 0000-00-00 | |
| S050 | ||
| S049 | 0000-00-00 | |
| S048 | 0000-00-00 | |
| S047 | 0000-00-00 | |
| S046 | 0000-00-00 | |
| S045 | 0000-00-00 | |
| S044 | 0000-00-00 | |
| S043 | 1990-05-08 | Normal 180 Day Track |
| S042 | 0000-00-00 | |
| S041 | 0000-00-00 | |
| S040 | 0000-00-00 | |
| S039 | 0000-00-00 | |
| S038 | 0000-00-00 | |
| S037 | 0000-00-00 | |
| S036 | 0000-00-00 | |
| S035 | 0000-00-00 | |
| S034 | 0000-00-00 | |
| S033 | 0000-00-00 | |
| S032 | 0000-00-00 | |
| S031 | 0000-00-00 | |
| S030 | 0000-00-00 | |
| S029 | 0000-00-00 | |
| S028 | 0000-00-00 | |
| S027 | ||
| S026 | 0000-00-00 | |
| S025 | 0000-00-00 | |
| S024 | 0000-00-00 | |
| S023 | 0000-00-00 | |
| S022 | 1987-01-15 | Normal 180 Day Track |
| S021 | 0000-00-00 | |
| S020 | 0000-00-00 | |
| S019 | 0000-00-00 | |
| S018 | 0000-00-00 | |
| S017 | 0000-00-00 | |
| S016 | 1986-05-06 | |
| S015 | 0000-00-00 | |
| S014 | 0000-00-00 | |
| S013 | 0000-00-00 | |
| S012 | 0000-00-00 | |
| S011 | 0000-00-00 | |
| S010 | 0000-00-00 | |
| S009 | 0000-00-00 | |
| S008 | 1985-02-21 | |
| S007 | 0000-00-00 | |
| S006 | 0000-00-00 | |
| S005 | 0000-00-00 | |
| S004 | ||
| S003 | 0000-00-00 | |
| S002 | 0000-00-00 | |
| S001 | 1984-07-02 |