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 alternate manufacturing facility located at guidant ireland, cashel road, clonmel tipperary, ireland and an alternate sterilization sited located at isotron ireland ltd. , sragh industrial estate, tullamore, co. Offaly, ireland.
| Device | MERIDEAN, DISCOVERY AND PULSAR PACEMAKERS |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1999-06-07 |
| Decision Date | 1999-06-29 |
| PMA | P940031 |
| Supplement | S019 |
| 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 |
|---|---|---|
| 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 |