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 | GEMINI(R) THETA MODEL 415A CARDIAC PACER |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | TELECTRONICS PACING SYSTEMS, INC. |
| Date Received | 1986-07-11 |
| Decision Date | 1986-10-20 |
| PMA | P830007 |
| Supplement | S017 |
| 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 | TELECTRONICS PACING SYSTEMS, INC. 7400 South Tucson Way englewood, CO 80112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830007 | Original Filing | |
| S032 | 1990-04-19 | Normal 180 Day Track |
| S031 | 1990-01-16 | Normal 180 Day Track |
| S030 | 1989-10-30 | Normal 180 Day Track |
| S029 | 1989-04-03 | Normal 180 Day Track |
| S028 | 1988-06-29 | Normal 180 Day Track |
| S027 | 1988-06-14 | Normal 180 Day Track |
| S026 | 1988-05-09 | Normal 180 Day Track |
| S025 | 1988-02-19 | Normal 180 Day Track |
| S024 | 1988-02-16 | Normal 180 Day Track |
| S023 | 1988-01-15 | Normal 180 Day Track |
| S022 | 1987-08-05 | Normal 180 Day Track |
| S021 | 1987-03-17 | 30-Day Supplement |
| S020 | 1987-01-21 | Special (immediate Track) |
| S019 | 1986-12-15 | Normal 180 Day Track |
| S018 | 1986-10-16 | Special (immediate Track) |
| S017 | 1986-07-11 | Normal 180 Day Track |
| S016 | 1985-12-05 | |
| S015 | 1985-11-20 | |
| S014 | 1985-10-15 | |
| S013 | 1985-08-09 | |
| S012 | 1985-07-12 | |
| S011 | ||
| S010 | 1985-06-03 | |
| S009 | 1985-05-30 | |
| S008 | ||
| S007 | 1985-02-25 | Normal 180 Day Track |
| S006 | 1985-01-08 | Normal 180 Day Track |
| S005 | 1985-01-08 | Normal 180 Day Track |
| S004 | 1984-10-15 | Normal 180 Day Track |
| S003 | 1984-01-17 | |
| S002 | ||
| S001 | 1983-09-23 |