Navistar, Navistar RMT, EZ Steer Nav Bi-directional

FDA Premarket Approval P990025 S062

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 addition of warnings from other catheter lines and the clarification of existing warnings and instructions

DeviceNavistar, Navistar RMT, EZ Steer Nav Bi-directional
Generic NameCatheter, Electrode Recording, Or Probe, Electrode Recording
Date Received2021-03-02
Decision Date2021-04-07
Product CodeDRF 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BIOSENSE WEBSTER, INC. 31 Technology Drive suite 200 irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P990025Original Filing
S064 2021-04-12 30-day Notice
S063 2021-03-31 30-day Notice
S062 2021-03-02 Special (immediate Track)
S061 2021-01-28 30-day Notice
S060 2020-09-15 30-day Notice
S059 2020-03-13 30-day Notice
S058 2020-01-16 30-day Notice
S057 2019-02-12 30-day Notice
S056 2018-07-02 30-day Notice
S055 2017-10-03 30-day Notice
S054 2017-09-11 30-day Notice
S053 2017-06-30 30-day Notice
S052 2017-06-02 135 Review Track For 30-day Notice
S051 2016-11-28 135 Review Track For 30-day Notice
S050 2016-08-26 30-day Notice
S049 2016-06-13 Normal 180 Day Track
S048 2016-03-31 30-day Notice
S047 2015-10-09 30-day Notice
S046 2015-05-06 30-day Notice
S045 2015-02-20 30-day Notice
S044 2015-02-20 30-day Notice
S043 2014-11-14 30-day Notice
S042 2014-09-29 Real-time Process
S041 2014-09-22 30-day Notice
S040 2014-07-02 Normal 180 Day Track No User Fee
S039 2013-12-27 30-day Notice
S038 2013-08-09 30-day Notice
S037 2013-04-26 30-day Notice
S036 2013-03-27 30-day Notice
S035 2013-03-21 135 Review Track For 30-day Notice
S034 2012-09-25 30-day Notice
S033 2012-06-19 30-day Notice
S032 2012-06-19 Normal 180 Day Track
S031 2012-04-16 Normal 180 Day Track
S030 2012-03-02 30-day Notice
S029 2011-08-29 30-day Notice
S028 2011-03-01 30-day Notice
S027 2011-01-31 30-day Notice
S026 2010-10-27 Normal 180 Day Track No User Fee
S025 2010-03-02 Normal 180 Day Track No User Fee
S024 2010-02-12 30-day Notice
S023 2010-02-05 30-day Notice
S022 2009-10-09 Real-time Process
S021 2009-09-28 Real-time Process
S018 2009-04-15 30-day Notice
S017 2009-02-18 Normal 180 Day Track
S016 2008-10-09 Special (immediate Track)
S015 2007-12-14 Normal 180 Day Track No User Fee
S014 2007-10-04 30-day Notice
S013 2007-07-31 30-day Notice
S012 2006-06-14 Normal 180 Day Track
S011 2006-01-18 Real-time Process
S010 2006-01-26 30-day Notice
S009 2005-04-27 Normal 180 Day Track
S008 2003-01-02 Real-time Process
S007 2002-08-23 Normal 180 Day Track
S006 2002-06-07 Real-time Process
S005 2002-04-17 Normal 180 Day Track
S004 2002-04-01 Normal 180 Day Track
S003 2000-12-21 30-day Notice
S002 2000-12-11 Normal 180 Day Track
S001 2000-07-31 Normal 180 Day Track


Device IDPMASupp
10846835000214 P990025 000
10846835000207 P990025 000
10846835008470 P990025 009

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