THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter, Navigation Catheter

FDA Premarket Approval P040036 S073

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

Alternative automated dimensional inspection process for ring spacing, tip length and shaft outer diameter for the thermocool smarttouch family of catheters.

DeviceTHERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter, Navigation Catheter
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantBIOSENSE WEBSTER, INC.
Date Received2020-04-13
Decision Date2020-04-30
PMAP040036
SupplementS073
Product CodeLPB 
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
P040036Original Filing
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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