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 use of an alternate tubing extrusion process for the pellethane(r) 55d used in the thinline(tm) family of pacing leads.
| Device | ADDITION OF ALTERNATE TUBING EXTRUDER |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1997-04-17 |
| Decision Date | 1997-10-23 |
| PMA | P960004 |
| Supplement | S002 |
| Product Code | DXY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process 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 |
|---|---|---|
| P960004 | Original Filing | |
| S101 | 2022-11-01 | 30-day Notice |
| S100 | 2022-07-26 | 30-day Notice |
| S099 | 2022-02-23 | 30-day Notice |
| S098 | 2021-09-30 | 30-day Notice |
| S097 | 2021-09-30 | 30-day Notice |
| S096 | 2021-09-23 | 30-day Notice |
| S095 | 2021-09-01 | 30-day Notice |
| S094 | 2021-04-30 | 30-day Notice |
| S093 | 2021-03-08 | 30-day Notice |
| S092 | 2021-01-11 | 30-day Notice |
| S091 | 2020-09-02 | 30-day Notice |
| S090 | 2019-05-03 | Normal 180 Day Track |
| S089 | 2019-03-13 | 30-day Notice |
| S088 | 2018-12-26 | Real-time Process |
| S087 | 2018-12-20 | 30-day Notice |
| S086 | 2018-07-13 | 30-day Notice |
| S085 | 2018-04-30 | Normal 180 Day Track |
| S084 | 2018-04-25 | 30-day Notice |
| S083 | 2018-03-26 | 30-day Notice |
| S082 | 2018-01-11 | 30-day Notice |
| S081 | 2017-05-26 | Normal 180 Day Track |
| S080 | 2017-04-26 | 30-day Notice |
| S079 | 2017-03-30 | 30-day Notice |
| S078 | 2016-12-09 | Normal 180 Day Track |
| S077 | 2016-07-07 | 30-day Notice |
| S076 | 2016-05-27 | 30-day Notice |
| S075 | 2015-11-20 | 135 Review Track For 30-day Notice |
| S074 | 2015-09-17 | 30-day Notice |
| S073 | 2015-09-01 | 30-day Notice |
| S072 | 2015-07-21 | 30-day Notice |
| S071 | ||
| S070 | 2015-06-22 | 30-day Notice |
| S069 | 2015-06-05 | 30-day Notice |
| S068 | 2015-04-20 | 30-day Notice |
| S067 | 2014-11-25 | 30-day Notice |
| S066 | 2014-06-30 | 30-day Notice |
| S065 | 2014-04-22 | 30-day Notice |
| S064 | 2013-11-08 | 30-day Notice |
| S063 | 2013-08-29 | 30-day Notice |
| S062 | ||
| S061 | 2013-05-16 | Real-time Process |
| S060 | 2013-06-26 | Normal 180 Day Track |
| S059 | 2013-03-27 | Normal 180 Day Track |
| S058 | 2012-11-08 | 30-day Notice |
| S057 | 2012-10-02 | 30-day Notice |
| S056 | 2012-09-10 | 30-day Notice |
| S055 | 2012-09-04 | 30-day Notice |
| S054 | 2012-07-26 | Real-time Process |
| S053 | 2012-06-19 | Real-time Process |
| S052 | 2012-06-18 | 30-day Notice |
| S051 | 2012-03-26 | 30-day Notice |
| S050 | 2012-01-24 | 30-day Notice |
| S049 | 2011-04-01 | 30-day Notice |
| S048 | 2011-02-22 | 30-day Notice |
| S047 | ||
| S046 | 2010-08-23 | 30-day Notice |
| S045 | 2009-12-18 | 30-day Notice |
| S044 | 2009-12-16 | 30-day Notice |
| S043 | ||
| S042 | 2008-12-08 | Real-time Process |
| S041 | 2008-08-25 | Real-time Process |
| S040 | ||
| S039 | 2007-03-19 | Real-time Process |
| S038 | 2006-08-01 | 135 Review Track For 30-day Notice |
| S037 | ||
| S036 | 2006-04-13 | 30-day Notice |
| S035 | 2006-04-13 | 30-day Notice |
| S034 | 2006-02-09 | 30-day Notice |
| S033 | ||
| S032 | 2005-12-22 | 30-day Notice |
| S031 | 2005-12-22 | 30-day Notice |
| S030 | 2005-12-22 | 30-day Notice |
| S029 | 2005-12-20 | 30-day Notice |
| S028 | 2005-02-24 | 30-day Notice |
| S027 | 2004-12-03 | 30-day Notice |
| S026 | 2004-10-21 | 30-day Notice |
| S025 | 2004-04-14 | 30-day Notice |
| S024 | 2004-01-13 | 30-day Notice |
| S023 | 2003-12-03 | Special (immediate Track) |
| S022 | 2003-06-03 | 30-day Notice |
| S021 | 2002-11-13 | 30-day Notice |
| S020 | 2001-11-16 | Real-time Process |
| S019 | 2001-10-04 | Real-time Process |
| S018 | 2001-02-20 | Real-time Process |
| S017 | 2000-12-26 | Normal 180 Day Track |
| S016 | ||
| S015 | 2000-08-21 | Normal 180 Day Track |
| S014 | 2000-05-26 | Normal 180 Day Track |
| S013 | 2000-05-15 | Normal 180 Day Track |
| S012 | 2000-05-15 | 30-day Notice |
| S011 | 2000-01-11 | Real-time Process |
| S010 | 1999-09-14 | Normal 180 Day Track |
| S009 | 1999-10-25 | Normal 180 Day Track |
| S008 | 1999-08-31 | Normal 180 Day Track |
| S007 | 1999-08-31 | 135 Review Track For 30-day Notice |
| S006 | 1999-06-23 | Normal 180 Day Track |
| S005 | 1999-06-14 | Real-time Process |
| S004 | ||
| S003 | ||
| S002 | 1997-04-17 | Normal 180 Day Track |
| S001 | 1997-01-27 | Normal 180 Day Track |