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 alternate manufacturing site for assembly of the external products (programmers, software modules/disks, external cardioverter defibrillators, and related accessories) which are used with cpi pacemaker and aicd systems. The proposed alternate manufacturing site (cardigan facility) is located at the following address:cpi cardigan facility, 599 cardigan road, shoreview, minnesota 55126
Device | DELTA PACEMAKER SYSTEM |
Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | BOSTON SCIENTIFIC |
Date Received | 1995-04-06 |
Decision Date | 1995-11-20 |
PMA | P840068 |
Supplement | S025 |
Product Code | LWP |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
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 |