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 silicone and polyurethane thinline(tm) ii sterox and fineline(tm) ii steroid eluting pacing leads. The devices are indicated for chronic pacing and sensing of the ventricle and/or atrium when used with a compatible pulse generator.
| Device | THINLINE II/ FINELINE II |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2000-05-26 |
| Decision Date | 2000-11-21 |
| PMA | P960004 |
| Supplement | S014 |
| Product Code | DTB |
| 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 |
|---|---|---|
| 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 |