EZ Steer DS Bi-Directional Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiology Catheter

FDA Premarket Approval P950005 S075

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 DS Bi-Directional Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiology Catheter
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantBiosense Webster, Inc
Date Received2020-09-15
Decision Date2020-09-24
PMAP950005
SupplementS075
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 Dr. irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P950005Original Filing
S075 2020-09-15 30-day Notice
S074 2020-03-13 30-day Notice
S073 2020-01-16 30-day Notice
S072 2019-07-30 30-day Notice
S071 2019-02-12 30-day Notice
S070 2018-07-02 30-day Notice
S069 2017-11-27 135 Review Track For 30-day Notice
S068 2017-10-03 30-day Notice
S067 2017-09-11 30-day Notice
S066 2017-06-30 30-day Notice
S065 2017-06-29 30-day Notice
S064 2017-06-02 135 Review Track For 30-day Notice
S063 2016-11-28 135 Review Track For 30-day Notice
S062 2016-08-26 30-day Notice
S061 2016-06-13 Normal 180 Day Track
S060 2016-03-31 30-day Notice
S059 2015-10-09 30-day Notice
S058 2015-07-17 30-day Notice
S057 2015-05-06 30-day Notice
S056 2015-02-20 30-day Notice
S055 2014-11-14 30-day Notice
S054 2014-09-29 Real-time Process
S053 2014-09-22 30-day Notice
S052 2014-08-14 30-day Notice
S051 2014-07-02 Normal 180 Day Track No User Fee
S050 2014-04-03 135 Review Track For 30-day Notice
S049 2013-12-27 30-day Notice
S048 2013-10-18 30-day Notice
S047 2013-11-01 Real-time Process
S046 2013-09-13 30-day Notice
S045 2013-08-09 30-day Notice
S044 2013-04-26 30-day Notice
S043 2013-03-27 30-day Notice
S042 2013-03-21 135 Review Track For 30-day Notice
S041 2012-11-07 Normal 180 Day Track
S040 2012-09-25 30-day Notice
S039 2012-06-19 30-day Notice
S038 2012-06-19 Normal 180 Day Track
S037 2012-04-16 Normal 180 Day Track
S036 2011-11-21 30-day Notice
S035 2011-08-29 30-day Notice
S034 2011-03-01 30-day Notice
S033 2011-03-01 135 Review Track For 30-day Notice
S032 2011-01-31 30-day Notice
S031 2010-10-27 Normal 180 Day Track No User Fee
S030 2010-03-02 Normal 180 Day Track No User Fee
S029 2010-02-12 30-day Notice
S028 2009-09-28 Real-time Process
S027
S026 2009-04-15 30-day Notice
S025 2009-02-18 Normal 180 Day Track
S024 2007-12-14 Normal 180 Day Track No User Fee
S023 2007-10-04 30-day Notice
S022 2007-09-28 Real-time Process
S021 2007-07-24 30-day Notice
S020 2006-01-26 30-day Notice
S019 2005-09-06 Normal 180 Day Track
S018 2004-09-28 Normal 180 Day Track
S017 2003-01-02 Real-time Process
S016 2002-06-07 Real-time Process
S015 2002-04-17 Normal 180 Day Track
S014 2001-05-29 Normal 180 Day Track
S013 2001-05-23 Real-time Process
S012 2001-04-13 Normal 180 Day Track
S011 2001-02-21 Normal 180 Day Track
S010 2000-12-08 Normal 180 Day Track
S009 2000-07-31 Normal 180 Day Track
S008 2000-04-19 Normal 180 Day Track
S007 1999-11-26 Real-time Process
S006 1999-08-02
S005
S004 1999-02-22 Real-time Process
S003 1998-07-27 Normal 180 Day Track
S002 1998-03-23 Normal 180 Day Track
S001 1997-11-10 Normal 180 Day Track

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