Blazer II Cardiac Ablation Catheter and Cable

Cardiac Ablation Percutaneous Catheter

FDA Premarket Approval P920047 S118

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 Cardiac Ablation Catheter and Cable
Classification NameCardiac Ablation Percutaneous Catheter
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantBoston Scientific Corp.
Date Received2019-10-10
Decision Date2019-11-07
PMAP920047
SupplementS118
Product CodeLPB
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134

Supplemental Filings

Supplement NumberDateSupplement Type
P920047Original Filing
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

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