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 swm 600 version do5u01 software module for use with the model pms 600 programmer
Device | BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01 |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | BIOTRONIK, INC. |
Date Received | 1994-11-16 |
Decision Date | 1995-09-07 |
PMA | P820076 |
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 | 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 |