Blazer Prime XP and IntellaTip MiFi XP

FDA Premarket Approval P020025 S124

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

Addition of bsc heredia as an alternate supplier for the steering control wire sub-assembly

DeviceBlazer Prime XP and IntellaTip MiFi XP
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantBOSTON SCIENTIFIC
Date Received2020-01-15
Decision Date2020-02-07
PMAP020025
SupplementS124
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
S124 2020-01-15 30-day Notice
S123 2019-11-22 Real-time Process
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.