THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Cath

FDA Premarket Approval P030031 S107

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

The implementation of an automated manufacturing process for a peek shaft component

DeviceTHERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Cath
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantBIOSENSE WEBSTER, INC.
Date Received2020-06-25
Decision Date2020-07-10
PMAP030031
SupplementS107
Product CodeOAD 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BIOSENSE WEBSTER, INC. 33 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P030031Original Filing
S107 2020-06-25 30-day Notice
S106 2020-06-05 30-day Notice
S105 2020-04-13 30-day Notice
S104 2020-03-13 30-day Notice
S103 2020-03-05 30-day Notice
S102
S101 2020-01-16 30-day Notice
S100
S099 2019-07-30 30-day Notice
S098
S097 2019-04-10 30-day Notice
S096 2019-02-12 30-day Notice
S095
S094 2018-12-26 Real-time Process
S093 2018-11-05 Special (immediate Track)
S092 2018-10-18 Normal 180 Day Track No User Fee
S091
S090 2018-07-06 30-day Notice
S089 2018-07-02 30-day Notice
S088 2018-06-21 30-day Notice
S087 2017-12-14 30-day Notice
S086 2017-12-04 Normal 180 Day Track
S085 2017-10-27 Normal 180 Day Track No User Fee
S084 2017-10-03 30-day Notice
S083 2017-09-11 30-day Notice
S082 2017-08-08 Special (immediate Track)
S081 2017-06-30 30-day Notice
S080 2017-06-02 135 Review Track For 30-day Notice
S079 2016-10-26 30-day Notice
S078 2016-09-29 30-day Notice
S077 2016-08-26 30-day Notice
S076 2016-08-24 30-day Notice
S075 2016-06-28 30-day Notice
S074 2016-06-13 Normal 180 Day Track
S073 2016-03-31 30-day Notice
S072 2016-02-01 Normal 180 Day Track
S071 2015-10-09 30-day Notice
S070 2015-07-17 30-day Notice
S069 2015-07-08 30-day Notice
S068 2015-05-06 30-day Notice
S067 2015-02-20 30-day Notice
S066 2015-02-20 30-day Notice
S065 2014-12-10 Normal 180 Day Track
S064 2014-11-14 30-day Notice
S063 2014-10-30 Special (immediate Track)
S062 2014-09-29 Real-time Process
S061 2014-09-15 30-day Notice
S060 2014-08-14 30-day Notice
S059 2014-07-02 Normal 180 Day Track No User Fee
S058 2013-12-27 30-day Notice
S057 2013-09-13 30-day Notice
S056
S055 2013-08-09 30-day Notice
S054 2013-07-15 30-day Notice
S053 2013-06-17 Normal 180 Day Track
S052 2013-04-26 30-day Notice
S051 2013-03-27 30-day Notice
S050 2013-03-21 135 Review Track For 30-day Notice
S049
S048 2012-09-25 30-day Notice
S047 2012-08-24 30-day Notice
S046
S045 2012-08-03 Real-time Process
S044 2012-07-03 Normal 180 Day Track No User Fee
S043 2012-06-28 30-day Notice
S042 2012-06-19 Normal 180 Day Track
S041 2012-04-16 Normal 180 Day Track
S040 2012-03-02 30-day Notice
S039 2012-02-21 Normal 180 Day Track No User Fee
S038 2012-01-23 Real-time Process
S037 2011-11-21 30-day Notice
S036 2011-10-19 Real-time Process
S035 2011-08-29 30-day Notice
S034 2011-06-20 Normal 180 Day Track
S033 2011-04-27 135 Review Track For 30-day Notice
S032 2011-03-01 30-day Notice
S031 2011-02-03 Normal 180 Day Track No User Fee
S030 2010-06-09 30-day Notice
S029 2010-04-22 30-day Notice
S028 2010-03-02 Normal 180 Day Track No User Fee
S027 2010-02-12 30-day Notice
S026 2010-02-05 30-day Notice
S025 2010-01-15 Normal 180 Day Track
S024 2010-01-14 135 Review Track For 30-day Notice
S023 2009-12-11 135 Review Track For 30-day Notice
S022 2009-11-17 Normal 180 Day Track
S021 2009-10-09 Real-time Process
S020 2009-10-06 Normal 180 Day Track No User Fee
S019 2009-10-01 Real-time Process
S018 2009-09-28 Real-time Process
S017
S016
S015
S014 2009-03-06 Normal 180 Day Track No User Fee
S013 2008-11-04 Normal 180 Day Track No User Fee
S012 2008-10-09 Special (immediate Track)
S011 2008-08-13 Panel Track
S010 2008-07-11 Normal 180 Day Track
S009 2007-11-23 Normal 180 Day Track
S008 2007-10-10 30-day Notice
S007 2007-10-04 30-day Notice
S006 2007-09-17 Normal 180 Day Track No User Fee
S005 2007-03-30 Normal 180 Day Track
S004 2006-12-01 Real-time Process
S003 2006-01-26 30-day Notice
S002 2005-09-16 Normal 180 Day Track No User Fee
S001 2004-12-17 Normal 180 Day Track No User Fee

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