EZ Steer NAV DS Bi-Directional Electrophysiology Catheter

FDA Premarket Approval P010068 S060

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

Implementing an alternate laser wire stripping process

DeviceEZ Steer NAV DS Bi-Directional Electrophysiology Catheter
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantBIOSENSE WEBSTER, INC.
Date Received2020-09-15
Decision Date2020-09-24
PMAP010068
SupplementS060
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
P010068Original Filing
S060 2020-09-15 30-day Notice
S059 2020-03-13 30-day Notice
S058 2020-01-16 30-day Notice
S057 2018-07-02 30-day Notice
S056 2017-10-03 30-day Notice
S055 2017-09-11 30-day Notice
S054 2017-06-30 30-day Notice
S053 2017-06-02 135 Review Track For 30-day Notice
S052 2016-08-26 30-day Notice
S051 2016-06-13 Normal 180 Day Track
S050 2016-03-31 30-day Notice
S049 2015-10-09 30-day Notice
S048 2015-07-17 30-day Notice
S047 2015-05-06 30-day Notice
S046 2015-02-20 30-day Notice
S045 2015-02-20 30-day Notice
S044 2014-11-14 30-day Notice
S043 2014-09-29 Real-time Process
S042 2014-09-22 30-day Notice
S041 2014-08-14 30-day Notice
S040 2014-07-02 Normal 180 Day Track No User Fee
S039 2014-04-03 135 Review Track For 30-day Notice
S038 2013-12-27 30-day Notice
S037 2013-10-18 30-day Notice
S036 2013-11-01 Real-time Process
S035 2013-08-09 30-day Notice
S034 2013-04-26 30-day Notice
S033 2013-03-27 30-day Notice
S032 2013-03-21 135 Review Track For 30-day Notice
S031 2012-11-07 Normal 180 Day Track
S030 2012-09-25 30-day Notice
S029 2012-06-19 30-day Notice
S028 2012-06-19 Normal 180 Day Track
S027 2012-04-16 Normal 180 Day Track
S026 2012-03-02 30-day Notice
S025 2011-08-29 30-day Notice
S024 2011-03-01 30-day Notice
S023 2011-03-01 135 Review Track For 30-day Notice
S022 2011-01-31 30-day Notice
S021 2010-10-27 Normal 180 Day Track No User Fee
S020 2010-03-02 Normal 180 Day Track No User Fee
S019 2010-02-05 30-day Notice
S018 2009-10-09 Real-time Process
S017 2009-09-28 Real-time Process
S016
S015
S014 2009-04-15 30-day Notice
S013 2008-10-09 Special (immediate Track)
S012 2007-12-14 Normal 180 Day Track No User Fee
S011 2007-10-04 30-day Notice
S010 2007-07-31 30-day Notice
S009 2006-01-31 Normal 180 Day Track
S008 2006-01-26 30-day Notice
S007 2005-09-22 Normal 180 Day Track No User Fee
S006 2005-09-06 Normal 180 Day Track
S005 2004-11-03 Normal 180 Day Track No User Fee
S004 2004-07-28 Real-time Process
S003 2004-03-11 Normal 180 Day Track No User Fee
S002 2003-11-03 Real-time Process
S001 2003-01-02 Real-time Process

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