CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH (ST), THERMOCOOL SMAR

FDA Premarket Approval P030031 S127

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

DeviceCELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH (ST), THERMOCOOL SMAR
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantBIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP030031 Supplement NumberS127 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-06-10
Decision Date2022-09-09
PMAP030031
SupplementS127
Product CodeOAD 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressBIOSENSE WEBSTER, INC.
31 Technology Drive
suite 200
irvine, CA 92618 PMA NumberP030031 Supplement NumberS127 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
software And Hardware Modifications For The NGEN Generator (compatible With The THERMOCOOL, NAVISTAR, And CELSIUS Catheters)

Supplemental Filings

Supplement NumberDateSupplement Type
P030031Original Filing
S128 2022-09-02 30-day Notice
S127 2022-06-10 Normal 180 Day Track
S126
S125 2021-10-20 Real-time Process
S124 2021-08-23 Normal 180 Day Track No User Fee
S123 2021-08-06 30-day Notice
S122
S121 2021-06-11 30-day Notice
S120
S119
S118 2021-04-12 Normal 180 Day Track No User Fee
S117 2021-04-12 30-day Notice
S116 2021-03-31 30-day Notice
S115 2021-03-08 Special (immediate Track)
S114 2021-03-02 Special (immediate Track)
S113 2021-02-23 30-day Notice
S112 2021-01-28 30-day Notice
S111 2021-01-07 30-day Notice
S110
S109
S108 2020-09-15 30-day Notice
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

NIH GUDID Devices

Device IDPMASupp
10846835018554 P030031 000
10846835003338 P030031 000
10846835003352 P030031 000
10846835003376 P030031 000
10846835003390 P030031 000
10846835000443 P030031 000
10846835000450 P030031 000
10846835000559 P030031 000
10846835000566 P030031 000
10846835000573 P030031 000
10846835003314 P030031 000
10846835006728 P030031 000
10846835018578 P030031 000
10846835018585 P030031 000
10846835002867 P030031 000
10846835002874 P030031 000
10846835002898 P030031 000
10846835002881 P030031 000
10846835002904 P030031 000
10846835008357 P030031 000
10846835006742 P030031 000
10846835008333 P030031 000
10846835003901 P030031 019
10846835009255 P030031 034
10846835009231 P030031 034
10846835009330 P030031 034
10846835009347 P030031 034
10846835009323 P030031 034
10846835009316 P030031 034
10846835009309 P030031 034
10846835009293 P030031 034
10846835009262 P030031 034
10846835009248 P030031 034
10846835009279 P030031 034
10846835009286 P030031 034
10846835009200 P030031 053
10846835008982 P030031 053
10846835009002 P030031 053
10846835009019 P030031 053
10846835009163 P030031 053
10846835009170 P030031 053
10846835009187 P030031 053
10846835009194 P030031 053
10846835010176 P030031 072
10846835010169 P030031 072
10846835010152 P030031 072
10846835010145 P030031 072
10846835009781 P030031 072
10846835009798 P030031 072
10846835009774 P030031 072
10846835010183 P030031 072
10846835017885 P030031 086

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.