Navistar DS Electrophysiology Catheter

FDA Premarket Approval P010068 S058

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

Line 13 transfer and addition of new slim line dryer

DeviceNavistar DS Electrophysiology Catheter
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantBIOSENSE WEBSTER, INC.
Date Received2020-01-16
Decision Date2020-02-26
PMAP010068
SupplementS058
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
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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