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 an update to the model 2881 software application to include the delta/vista pacemakers, series, resulting in version 1. 3 of the model 2881 software application.
Device | DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) |
Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | BOSTON SCIENTIFIC |
Date Received | 1998-06-24 |
Decision Date | 1998-07-31 |
PMA | P840068 |
Supplement | S036 |
Product Code | LWP |
Advisory Committee | Cardiovascular |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112 |
Supplement Number | Date | Supplement Type |
---|---|---|
P840068 | Original Filing | |
S055 | 2021-03-08 | 30-day Notice |
S054 | 2019-03-13 | 30-day Notice |
S053 | 2013-08-29 | 30-day Notice |
S052 | 2012-11-08 | 30-day Notice |
S051 | 2012-10-10 | 30-day Notice |
S050 | 2012-03-24 | 30-day Notice |
S049 | 2011-04-01 | 30-day Notice |
S048 | 2011-03-18 | Real-time Process |
S047 | 2010-08-23 | Real-time Process |
S046 | 2007-08-23 | Normal 180 Day Track |
S045 | ||
S044 | 2006-06-26 | 30-day Notice |
S043 | 2004-12-03 | 30-day Notice |
S042 | 2004-10-21 | 30-day Notice |
S041 | 2001-04-06 | Real-time Process |
S040 | 2000-07-25 | Normal 180 Day Track |
S039 | 1999-12-20 | Normal 180 Day Track |
S038 | 1999-10-06 | Real-time Process |
S037 | 1998-08-05 | Real-time Process |
S036 | 1998-06-24 | Real-time Process |
S035 | 1998-05-07 | Real-time Process |
S034 | 1998-03-04 | Real-time Process |
S033 | 1997-07-18 | Real-time Process |
S032 | 1996-12-23 | Normal 180 Day Track |
S031 | 1997-01-17 | Normal 180 Day Track |
S030 | 1996-10-16 | Normal 180 Day Track |
S029 | 1996-03-25 | Normal 180 Day Track |
S028 | 1995-09-11 | Normal 180 Day Track |
S027 | 1995-08-09 | Normal 180 Day Track |
S026 | 1995-06-26 | Normal 180 Day Track |
S025 | 1995-04-06 | Normal 180 Day Track |
S024 | 1995-03-16 | Normal 180 Day Track |
S023 | 1994-12-14 | Normal 180 Day Track |
S022 | 1993-07-13 | Normal 180 Day Track |
S021 | 1993-07-13 | Normal 180 Day Track |
S020 | 1992-07-27 | Normal 180 Day Track |
S019 | 1992-05-05 | Normal 180 Day Track |
S018 | 1992-04-08 | Normal 180 Day Track |
S017 | 1991-11-07 | Normal 180 Day Track |
S016 | 1991-10-17 | Normal 180 Day Track |
S015 | 1991-07-02 | Normal 180 Day Track |
S014 | 1990-07-20 | Normal 180 Day Track |
S013 | 1990-07-17 | Normal 180 Day Track |
S012 | 1990-02-15 | Normal 180 Day Track |
S011 | 1990-01-25 | Normal 180 Day Track |
S010 | 1989-12-21 | Normal 180 Day Track |
S009 | 1989-10-31 | Normal 180 Day Track |
S008 | 1989-10-23 | Normal 180 Day Track |
S007 | 1988-08-02 | Normal 180 Day Track |
S006 | 1988-05-16 | Normal 180 Day Track |
S005 | 1988-04-04 | Normal 180 Day Track |
S004 | 1987-10-06 | Normal 180 Day Track |
S003 | 1986-11-24 | Normal 180 Day Track |
S002 | 1986-03-20 | |
S001 | 1986-01-16 |