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.
Addition of a biocompatible adhesive to the lead which will enhance the ability to maintain the position of the drug-eluting collar at its designed location.
| Device | THINLINE II STEROX /FINELINE II STEROX ENDOCARDIAL PACING LEADS |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2003-06-03 |
| Decision Date | 2003-07-02 |
| PMA | P960004 |
| Supplement | S022 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| 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 |