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 to move the extrusion process for blazer prime ablationcatheters to a new manufacturing line introducing an automated process to identify and cutmarked sections of the extruded shaft.
| Device | BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | Boston Scientific Corp. |
| Date Received | 2013-03-25 |
| Decision Date | 2013-07-22 |
| PMA | P920047 |
| Supplement | S058 |
| Product Code | LPB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920047 | Original Filing | |
| S129 | 2022-10-17 | 30-day Notice |
| S128 | 2022-08-22 | 30-day Notice |
| S127 | 2022-01-28 | 30-day Notice |
| S126 | 2022-01-24 | 30-day Notice |
| S125 | 2021-08-13 | 30-day Notice |
| S124 | 2020-12-18 | Normal 180 Day Track |
| S123 | 2020-03-30 | Real-time Process |
| S122 | 2020-03-12 | Normal 180 Day Track No User Fee |
| S121 | 2020-01-22 | 30-day Notice |
| S120 | 2020-01-15 | 30-day Notice |
| S119 | 2019-11-22 | Real-time Process |
| S118 | 2019-10-10 | 30-day Notice |
| S117 | 2019-08-09 | 30-day Notice |
| S116 | 2019-04-12 | Real-time Process |
| S115 | 2019-04-08 | 30-day Notice |
| S114 | 2019-03-21 | 30-day Notice |
| S113 | 2018-10-30 | 30-day Notice |
| S112 | 2018-10-25 | 135 Review Track For 30-day Notice |
| S111 | 2018-08-24 | 30-day Notice |
| S110 | 2018-06-21 | Normal 180 Day Track |
| S109 | 2018-06-13 | 30-day Notice |
| S108 | 2018-04-06 | 135 Review Track For 30-day Notice |
| S107 | 2018-01-17 | 30-day Notice |
| S106 | 2017-10-30 | 30-day Notice |
| S105 | 2017-10-02 | 30-day Notice |
| S104 | 2017-09-29 | Normal 180 Day Track |
| S103 | 2017-09-14 | 30-day Notice |
| S102 | 2017-08-30 | 30-day Notice |
| S101 | 2017-08-04 | 30-day Notice |
| S100 | 2017-07-18 | 30-day Notice |
| S099 | 2017-06-26 | 30-day Notice |
| S098 | 2017-04-27 | Real-time Process |
| S097 | 2017-04-13 | 30-day Notice |
| S096 | 2017-03-06 | 30-day Notice |
| S095 | 2016-11-22 | 30-day Notice |
| S094 | 2016-07-21 | 30-day Notice |
| S093 | ||
| S092 | 2016-05-11 | Real-time Process |
| S091 | 2016-04-15 | 135 Review Track For 30-day Notice |
| S090 | 2016-02-12 | 30-day Notice |
| S089 | 2016-02-12 | 30-day Notice |
| S088 | 2015-11-20 | 135 Review Track For 30-day Notice |
| S087 | 2015-11-19 | 30-day Notice |
| S086 | 2015-09-10 | 30-day Notice |
| S085 | 2015-09-03 | 30-day Notice |
| S084 | 2015-08-18 | Special (immediate Track) |
| S083 | 2015-06-29 | Normal 180 Day Track No User Fee |
| S082 | ||
| S081 | 2015-04-29 | 30-day Notice |
| S080 | 2015-04-29 | Special (immediate Track) |
| S079 | 2015-04-28 | 30-day Notice |
| S078 | 2015-04-13 | 30-day Notice |
| S077 | 2015-03-12 | 30-day Notice |
| S076 | 2015-01-13 | Real-time Process |
| S075 | 2014-11-19 | 30-day Notice |
| S074 | 2014-09-22 | 30-day Notice |
| S073 | 2014-06-13 | Normal 180 Day Track No User Fee |
| S072 | 2014-06-10 | Normal 180 Day Track |
| S071 | 2014-05-05 | Normal 180 Day Track No User Fee |
| S070 | 2014-04-30 | 30-day Notice |
| S069 | 2014-03-31 | 30-day Notice |
| S068 | 2014-03-28 | 30-day Notice |
| S067 | 2014-03-04 | 30-day Notice |
| S066 | 2014-02-24 | 30-day Notice |
| S065 | 2014-01-14 | 30-day Notice |
| S064 | 2013-11-21 | 30-day Notice |
| S063 | 2013-10-31 | Special (immediate Track) |
| S062 | 2013-09-23 | 30-day Notice |
| S061 | 2013-09-19 | 30-day Notice |
| S060 | 2013-09-09 | Special (immediate Track) |
| S059 | 2013-08-29 | 30-day Notice |
| S058 | 2013-03-25 | 135 Review Track For 30-day Notice |
| S057 | 2013-03-21 | 30-day Notice |
| S056 | 2013-03-04 | 30-day Notice |
| S055 | 2013-01-24 | 30-day Notice |
| S054 | 2012-12-26 | 30-day Notice |
| S053 | 2012-09-03 | 30-day Notice |
| S052 | 2012-04-27 | 30-day Notice |
| S051 | 2012-03-23 | 30-day Notice |
| S050 | 2011-11-07 | 30-day Notice |
| S049 | 2011-09-19 | Real-time Process |
| S048 | 2011-06-21 | Normal 180 Day Track No User Fee |
| S047 | 2011-06-09 | Real-time Process |
| S046 | 2011-03-23 | 135 Review Track For 30-day Notice |
| S045 | 2011-02-28 | Normal 180 Day Track No User Fee |
| S044 | 2010-10-07 | 135 Review Track For 30-day Notice |
| S043 | 2010-07-27 | 30-day Notice |
| S042 | 2010-05-27 | 30-day Notice |
| S041 | 2010-01-26 | 30-day Notice |
| S040 | 2009-06-03 | Normal 180 Day Track No User Fee |
| S039 | 2009-04-06 | Normal 180 Day Track |
| S038 | 2008-09-15 | 30-day Notice |
| S037 | 2007-03-12 | Normal 180 Day Track No User Fee |
| S036 | 2006-09-21 | Real-time Process |
| S035 | 2006-08-21 | Real-time Process |
| S034 | 2006-05-16 | 30-day Notice |
| S033 | ||
| S032 | ||
| S031 | 2005-10-13 | Normal 180 Day Track No User Fee |
| S030 | 2005-09-22 | Normal 180 Day Track No User Fee |
| S029 | 2005-09-06 | 30-day Notice |
| S028 | 2005-07-18 | Normal 180 Day Track |
| S027 | 2005-05-19 | Real-time Process |
| S026 | 2005-01-24 | Real-time Process |
| S025 | 2004-12-17 | 30-day Notice |
| S024 | 2004-05-26 | Real-time Process |
| S023 | 2004-04-01 | Real-time Process |
| S022 | 2003-12-08 | 30-day Notice |
| S021 | 2003-11-03 | Normal 180 Day Track No User Fee |
| S020 | 2003-10-27 | 30-day Notice |
| S019 | 2003-05-05 | Normal 180 Day Track No User Fee |
| S018 | 2002-08-28 | Normal 180 Day Track |
| S017 | 2002-08-07 | Real-time Process |
| S016 | 2001-11-23 | 30-day Notice |
| S015 | 2001-11-07 | Normal 180 Day Track |
| S014 | 2001-03-26 | 30-day Notice |
| S013 | 1999-11-05 | 30-day Notice |
| S012 | 1999-03-23 | Real-time Process |
| S011 | ||
| S010 | 1998-10-06 | Normal 180 Day Track |
| S009 | 1997-10-15 | Normal 180 Day Track |
| S008 | 1997-08-15 | Normal 180 Day Track |
| S007 | 1997-02-11 | Normal 180 Day Track |
| S006 | 1996-10-24 | Normal 180 Day Track |
| S005 | 1995-03-30 | Special (immediate Track) |
| S004 | 1995-01-12 | Normal 180 Day Track |
| S003 | 1994-12-05 | Normal 180 Day Track |
| S002 | 1994-11-21 | Normal 180 Day Track |
| S001 | 1994-11-17 | Normal 180 Day Track |