NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST)

FDA Premarket Approval P040036 S089

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

DeviceNAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST)
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantBIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP040036 Supplement NumberS089 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB  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
PMAP040036
SupplementS089
Product CodeLPB 
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 NumberP040036 Supplement NumberS089 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB  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
P040036Original Filing
S089 2022-06-10 Normal 180 Day Track
S088
S087 2021-10-20 Real-time Process
S086 2021-08-23 Normal 180 Day Track No User Fee
S085 2021-08-06 30-day Notice
S084
S083 2021-06-11 30-day Notice
S082
S081 2021-04-12 30-day Notice
S080 2021-03-31 30-day Notice
S079 2021-03-02 Special (immediate Track)
S078 2021-02-23 30-day Notice
S077 2021-01-28 30-day Notice
S076 2021-01-07 30-day Notice
S075 2020-06-25 30-day Notice
S074 2020-06-05 30-day Notice
S073 2020-04-13 30-day Notice
S072 2020-03-13 30-day Notice
S071 2020-03-05 30-day Notice
S070
S069 2020-01-16 30-day Notice
S068 2019-07-30 30-day Notice
S067 2019-04-10 30-day Notice
S066 2019-02-12 30-day Notice
S065
S064 2018-12-26 Real-time Process
S063 2018-07-06 30-day Notice
S062 2017-12-14 30-day Notice
S061 2017-10-03 30-day Notice
S060 2017-08-08 Special (immediate Track)
S059 2017-06-30 30-day Notice
S058 2017-06-02 135 Review Track For 30-day Notice
S057 2016-08-26 30-day Notice
S056 2016-06-28 30-day Notice
S055 2016-06-13 Normal 180 Day Track
S054 2016-03-31 30-day Notice
S053 2015-10-09 30-day Notice
S052 2015-07-17 30-day Notice
S051 2015-07-08 30-day Notice
S050 2015-02-20 30-day Notice
S049 2015-02-20 30-day Notice
S048 2014-12-10 Normal 180 Day Track
S047 2014-10-30 Special (immediate Track)
S046 2014-09-29 Real-time Process
S045 2014-08-14 30-day Notice
S044 2014-07-02 Normal 180 Day Track No User Fee
S043 2014-05-23 Normal 180 Day Track No User Fee
S042
S041 2013-12-27 30-day Notice
S040 2013-09-13 30-day Notice
S039 2013-08-09 30-day Notice
S038 2013-07-15 30-day Notice
S037 2013-06-17 Normal 180 Day Track
S036 2013-04-26 30-day Notice
S035 2013-03-27 30-day Notice
S034
S033 2013-03-21 135 Review Track For 30-day Notice
S032 2012-07-03 Normal 180 Day Track No User Fee
S031 2012-06-19 Normal 180 Day Track
S030 2012-04-16 Normal 180 Day Track
S029 2012-03-02 30-day Notice
S028 2011-11-21 30-day Notice
S027 2011-10-19 Real-time Process
S026 2011-08-29 30-day Notice
S025
S024 2011-04-27 135 Review Track For 30-day Notice
S023 2011-03-01 30-day Notice
S022 2010-04-22 30-day Notice
S021 2010-03-02 Normal 180 Day Track No User Fee
S020 2010-02-12 30-day Notice
S019 2010-02-05 30-day Notice
S018
S017 2010-01-14 135 Review Track For 30-day Notice
S016 2009-12-11 135 Review Track For 30-day Notice
S015 2009-11-17 Normal 180 Day Track
S014 2009-10-09 Real-time Process
S013 2009-09-28 Real-time Process
S012
S011
S010
S009 2008-10-09 Special (immediate Track)
S008 2008-07-11 Normal 180 Day Track
S007 2008-07-01 Normal 180 Day Track No User Fee
S006 2007-11-23 Normal 180 Day Track
S005 2007-10-10 30-day Notice
S004 2007-10-04 30-day Notice
S003 2007-03-30 Normal 180 Day Track
S002 2006-12-01 Real-time Process
S001 2006-10-19 Normal 180 Day Track No User Fee

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