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 | DIPLOS MODEL 03 |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BIOTRONIK, INC. |
| Date Received | 1985-06-10 |
| Decision Date | 1986-03-06 |
| PMA | P820076 |
| Supplement | S003 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820076 | Original Filing | |
| S028 | 2018-07-10 | 30-day Notice |
| S027 | 2018-06-14 | 135 Review Track For 30-day Notice |
| S026 | 2018-01-22 | 30-day Notice |
| S025 | 2011-06-16 | 135 Review Track For 30-day Notice |
| S024 | 2008-05-14 | Real-time Process |
| S023 | 2002-11-20 | 30-day Notice |
| S022 | 1999-08-13 | Normal 180 Day Track |
| S021 | 1998-04-24 | Normal 180 Day Track |
| S020 | 1995-05-04 | Normal 180 Day Track |
| S019 | 1995-05-02 | Normal 180 Day Track |
| S018 | 1995-02-27 | Normal 180 Day Track |
| S017 | 1994-11-16 | Normal 180 Day Track |
| S016 | 1993-10-06 | Normal 180 Day Track |
| S015 | 1993-02-19 | Normal 180 Day Track |
| S014 | 1991-12-23 | Normal 180 Day Track |
| S013 | 1991-09-18 | Normal 180 Day Track |
| S012 | 1991-05-06 | Normal 180 Day Track |
| S011 | 1991-01-08 | Normal 180 Day Track |
| S010 | 1990-12-31 | Normal 180 Day Track |
| S009 | 1990-03-12 | Normal 180 Day Track |
| S008 | 1989-12-07 | Normal 180 Day Track |
| S007 | 1989-07-20 | Normal 180 Day Track |
| S006 | 1988-07-05 | Normal 180 Day Track |
| S005 | 1988-06-17 | Normal 180 Day Track |
| S004 | 1987-10-16 | Normal 180 Day Track |
| S003 | 1985-06-10 | |
| S002 | 1985-02-20 | |
| S001 | 1984-10-22 |