Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

FDA Premarket Approval P990025 S063

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

Approval for a new ethylene oxide (eo) sterilization cycle (j&j consolidated cycle 1) at the steris isomedix services (steris sd) facility in san diego, ca

DeviceBiosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter
Generic NameCatheter, Electrode Recording, Or Probe, Electrode Recording
ApplicantBIOSENSE WEBSTER, INC.
Date Received2021-03-31
Decision Date2021-04-28
PMAP990025
SupplementS063
Product CodeDRF 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
S020
S019
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

NIH GUDID Devices

Device IDPMASupp
10846835000214 P990025 000
10846835000207 P990025 000
10846835008470 P990025 009

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