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 vigor model 2880 software application, version 4. 1, which corrects anomalies discovered during clinical use of the programmer software.
| Device | MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1998-05-07 |
| Decision Date | 1998-05-28 |
| PMA | P940031 |
| Supplement | S013 |
| 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 |
|---|---|---|
| P940031 | Original Filing | |
| S079 | 2021-03-08 | 30-day Notice |
| S078 | 2019-03-13 | 30-day Notice |
| S077 | 2014-04-22 | 30-day Notice |
| S076 | 2014-02-21 | Real-time Process |
| S075 | 2013-08-29 | 30-day Notice |
| S074 | 2012-11-08 | 30-day Notice |
| S073 | 2012-10-02 | 30-day Notice |
| S072 | 2012-03-26 | 30-day Notice |
| S071 | 2011-04-01 | 30-day Notice |
| S070 | 2011-03-18 | Real-time Process |
| S069 | 2010-08-23 | Real-time Process |
| S068 | 2010-07-15 | 30-day Notice |
| S067 | 2010-04-20 | 30-day Notice |
| S066 | 2010-02-04 | 30-day Notice |
| S065 | 2009-05-22 | 135 Review Track For 30-day Notice |
| S064 | 2008-06-18 | 30-day Notice |
| S063 | 2008-06-03 | 30-day Notice |
| S062 | 2007-11-09 | 30-day Notice |
| S061 | 2007-08-23 | Normal 180 Day Track |
| S060 | 2006-11-06 | 30-day Notice |
| S059 | 2006-11-01 | Real-time Process |
| S058 | ||
| S057 | 2006-06-26 | 30-day Notice |
| S056 | ||
| S055 | 2006-05-12 | Normal 180 Day Track |
| S054 | 2006-05-02 | 135 Review Track For 30-day Notice |
| S053 | 2006-04-13 | 30-day Notice |
| S052 | 2006-03-28 | 30-day Notice |
| S051 | 2006-03-03 | 30-day Notice |
| S050 | 2006-03-03 | 135 Review Track For 30-day Notice |
| S049 | 2005-12-21 | 30-day Notice |
| S048 | ||
| S047 | 2005-11-16 | 30-day Notice |
| S046 | 2005-10-11 | 135 Review Track For 30-day Notice |
| S045 | 2005-10-03 | 135 Review Track For 30-day Notice |
| S044 | 2005-08-29 | 135 Review Track For 30-day Notice |
| S043 | 2005-08-25 | 30-day Notice |
| S042 | 2005-08-15 | 30-day Notice |
| S041 | ||
| S040 | ||
| S039 | 2005-08-09 | 30-day Notice |
| S038 | 2005-06-27 | 30-day Notice |
| S037 | 2005-06-27 | 30-day Notice |
| S036 | 2005-06-27 | 30-day Notice |
| S035 | 2005-06-23 | 30-day Notice |
| S034 | 2005-03-18 | Real-time Process |
| S033 | 2004-12-03 | 30-day Notice |
| S032 | 2004-10-21 | 30-day Notice |
| S031 | 2004-04-14 | 30-day Notice |
| S030 | 2004-01-13 | 30-day Notice |
| S029 | 2003-11-20 | 30-day Notice |
| S028 | 2003-09-08 | Real-time Process |
| S027 | 2002-12-12 | Normal 180 Day Track |
| S026 | 2001-04-06 | Real-time Process |
| S025 | 2001-01-19 | Real-time Process |
| S024 | 2000-05-09 | Real-time Process |
| S023 | 1999-12-20 | Normal 180 Day Track |
| S022 | 2000-01-27 | Real-time Process |
| S021 | 1999-10-04 | Real-time Process |
| S020 | 1999-09-30 | Real-time Process |
| S019 | 1999-06-07 | Normal 180 Day Track |
| S018 | 1999-03-03 | Real-time Process |
| S017 | 1998-07-30 | Real-time Process |
| S016 | 1998-08-24 | Real-time Process |
| S015 | 1998-07-01 | Normal 180 Day Track |
| S014 | 1998-08-05 | Real-time Process |
| S013 | 1998-05-07 | Real-time Process |
| S012 | 1998-03-04 | Real-time Process |
| S011 | 1997-10-24 | Normal 180 Day Track |
| S010 | 1997-07-18 | Real-time Process |
| S009 | 1996-12-23 | Normal 180 Day Track |
| S008 | 1997-01-17 | Normal 180 Day Track |
| S007 | 1996-11-20 | Normal 180 Day Track |
| S006 | 1996-10-16 | Normal 180 Day Track |
| S005 | 1996-03-25 | Normal 180 Day Track |
| S004 | 1996-01-25 | Normal 180 Day Track |
| S003 | 1995-09-11 | Normal 180 Day Track |
| S002 | 1995-08-09 | Normal 180 Day Track |
| S001 | 1995-06-26 | Normal 180 Day Track |