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 model pms 1000 programming and monitoring system with software module swm 1000, version c01. C02. U
Device | MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | BIOTRONIK, INC. |
Date Received | 1995-05-02 |
Decision Date | 1996-01-24 |
PMA | P820076 |
Supplement | S019 |
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 |