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 two new models of vista ddd pulse generators and a software module. The devices as modified will be marketed under the trade name vista ddd model 942, vista ddd model 944 and software module model 2052 with the commercially available handheld programmer model 2035
Device | VISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052 |
Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | BOSTON SCIENTIFIC |
Date Received | 1992-05-05 |
Decision Date | 1996-06-19 |
PMA | P840068 |
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 | 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 |