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.
Use of supplemental sterilization equipment and a new sterilization process for implantable leads and accessories.
Device | DIPLOS MODEL 05 A & B |
Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | BIOTRONIK, INC. |
Date Received | 2018-01-22 |
Decision Date | 2018-02-21 |
PMA | P820076 |
Supplement | S026 |
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 | 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 |