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 1)a new programming system, the model 2901 prm programming system with the commercially available vigor family of pulse generators and accessories, and 2) a new manufacturing cotract faciliyt, emd associates, inc. , (emd), 4065 theurer blvd. , winona, mn 55987
| Device | MODEL 2901 PROGRAMMERR SYSTEM |
| Classification Name | Programmer, Pacemaker |
| Generic Name | Programmer, Pacemaker |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1996-03-25 |
| Decision Date | 1996-11-07 |
| PMA | P940031 |
| Supplement | S005 |
| Product Code | KRG |
| 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 |
|---|---|---|
| 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 |