Blazer II XP Cardiac Ablation Catheter and Cable

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Premarket Approval P020025 S122

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.

Pre-market Approval Supplement Details

To reduce the ethylene oxide gas concentration and qualify additional process challenge devices used in the bsc2000-2 sterilization cycle

DeviceBlazer II XP Cardiac Ablation Catheter and Cable
Classification NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantBOSTON SCIENTIFIC
Date Received2019-10-10
Decision Date2019-11-07
PMAP020025
SupplementS122
Product CodeOAD
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC 150 Baytech Drive san Jose, CA 95134

Supplemental Filings

Supplement NumberDateSupplement Type
P020025Original Filing
S122 2019-10-10 30-day Notice
S121 2019-08-09 30-day Notice
S120 2019-04-12 Real-time Process
S119 2019-04-08 30-day Notice
S118
S117 2019-03-21 30-day Notice
S116 2018-10-30 30-day Notice
S115 2018-10-25 135 Review Track For 30-day Notice
S114 2018-08-24 30-day Notice
S113 2018-06-21 Normal 180 Day Track
S112 2018-06-13 30-day Notice
S111 2018-04-06 135 Review Track For 30-day Notice
S110 2018-01-17 30-day Notice
S109 2017-10-30 30-day Notice
S108 2017-10-02 30-day Notice
S107 2017-09-14 30-day Notice
S106 2017-08-30 30-day Notice
S105 2017-08-04 30-day Notice
S104 2017-07-18 30-day Notice
S103 2017-06-26 30-day Notice
S102 2017-06-08 30-day Notice
S101 2017-04-27 Real-time Process
S100 2017-04-13 30-day Notice
S099 2017-04-07 30-day Notice
S098 2017-03-29 Real-time Process
S097 2017-03-06 30-day Notice
S096 2017-03-03 Real-time Process
S095 2017-02-16 Normal 180 Day Track No User Fee
S094 2017-01-05 Real-time Process
S093 2016-11-22 30-day Notice
S092 2016-11-09 30-day Notice
S091 2016-09-01 135 Review Track For 30-day Notice
S090 2016-07-21 30-day Notice
S089
S088 2016-05-11 Real-time Process
S087 2016-04-15 135 Review Track For 30-day Notice
S086 2016-03-24 30-day Notice
S085 2016-03-24 30-day Notice
S084 2016-02-12 30-day Notice
S083 2016-02-12 30-day Notice
S082 2015-11-20 135 Review Track For 30-day Notice
S081 2015-11-19 30-day Notice
S080 2015-09-10 30-day Notice
S079 2015-09-03 30-day Notice
S078 2015-08-18 Special (immediate Track)
S077 2015-07-24 Normal 180 Day Track
S076 2015-06-29 Normal 180 Day Track No User Fee
S075 2015-06-23 Real-time Process
S074 2015-06-12 Special (immediate Track)
S073
S072 2015-05-13 30-day Notice
S071 2015-04-29 30-day Notice
S070 2015-04-28 30-day Notice
S069 2015-04-13 30-day Notice
S068 2015-03-12 30-day Notice
S067 2015-01-13 Real-time Process
S066 2014-12-17 30-day Notice
S065 2014-11-19 30-day Notice
S064 2014-09-22 30-day Notice
S063 2014-06-30 30-day Notice
S062 2014-06-16 30-day Notice
S061 2014-06-13 Normal 180 Day Track No User Fee
S060 2014-06-10 Normal 180 Day Track
S059 2014-05-05 Normal 180 Day Track No User Fee
S058 2014-04-30 30-day Notice
S057 2014-03-31 30-day Notice
S056 2014-03-28 30-day Notice
S055 2014-03-04 30-day Notice
S054 2014-02-24 30-day Notice
S053 2014-01-14 30-day Notice
S052 2014-01-09 30-day Notice
S051 2013-11-21 30-day Notice
S050 2013-11-04 30-day Notice
S049 2013-10-31 Special (immediate Track)
S048 2013-09-23 30-day Notice
S047 2013-09-19 30-day Notice
S046 2013-09-12 Real-time Process
S045 2013-09-12 Real-time Process
S044 2013-09-09 Special (immediate Track)
S043 2013-08-29 30-day Notice
S042 2013-07-15 30-day Notice
S041
S040 2013-03-21 30-day Notice
S039 2013-03-04 30-day Notice
S038 2013-01-24 30-day Notice
S037 2012-12-26 30-day Notice
S036 2012-11-02 Normal 180 Day Track
S035 2012-09-05 30-day Notice
S034 2012-04-27 30-day Notice
S033 2012-03-23 30-day Notice
S032 2011-11-07 30-day Notice
S031 2011-09-19 Real-time Process
S030 2011-07-20 30-day Notice
S029 2011-06-21 Normal 180 Day Track No User Fee
S028 2011-06-09
S027 2011-03-23 135 Review Track For 30-day Notice
S026 2011-02-28 Normal 180 Day Track No User Fee
S025 2010-10-07 135 Review Track For 30-day Notice
S024 2010-07-27 30-day Notice
S023 2010-05-27 30-day Notice
S022 2010-01-26 30-day Notice
S021 2009-06-03 Normal 180 Day Track No User Fee
S020 2009-04-06 Normal 180 Day Track
S019 2007-03-12 Normal 180 Day Track No User Fee
S018 2006-09-21 Real-time Process
S017 2006-05-16 30-day Notice
S016
S015 2005-10-13 Normal 180 Day Track No User Fee
S014 2005-09-22 Normal 180 Day Track No User Fee
S013 2005-09-06 30-day Notice
S012 2005-07-18 Normal 180 Day Track
S011 2005-05-19 Real-time Process
S010 2005-01-24 Real-time Process
S009
S008 2004-12-17 30-day Notice
S007 2004-09-15 30-day Notice
S006 2004-05-26 Real-time Process
S005 2004-05-24 Normal 180 Day Track No User Fee
S004 2003-12-18 Normal 180 Day Track
S003 2003-12-08 30-day Notice
S002 2003-11-03 Normal 180 Day Track No User Fee
S001 2003-09-24 Normal 180 Day Track

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