NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Premarket Approval P990025 S002

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 expanding the indications for use. The device, as modified, will be marketed under the trade name navistart deflectable tip diagnostic/ablation catheter and is indicated a follows: the biosense webster navi-star diagnostic/ablation catheter, and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping, and for use with a compatible rf generator in adults and children 4 years of age and older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. When used with the carto ep navigation system, the navi-star diagnostic/ablation catheter provides location information.

DeviceNAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER
Classification NameCatheter, Electrode Recording, Or Probe, Electrode Recording
Generic NameCatheter, Electrode Recording, Or Probe, Electrode Recording
ApplicantBIOSENSE WEBSTER, INC.
Date Received2000-12-11
Decision Date2001-09-26
PMAP990025
SupplementS002
Product CodeDRF
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BIOSENSE WEBSTER, INC. 33 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P990025Original Filing
S070 2022-09-02 30-day Notice
S069 2022-06-10 Normal 180 Day Track
S068 2021-08-23 Normal 180 Day Track No User Fee
S067
S066 2021-06-11 30-day Notice
S065
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
10846835001990 P990025 000
10846835001983 P990025 000
10846835001976 P990025 000
10846835001969 P990025 000
10846835001952 P990025 000
10846835001914 P990025 000
10846835001907 P990025 000
10846835001891 P990025 000
10846835000610 P990025 000
10846835000597 P990025 000
10846835008555 P990025 000
10846835000207 P990025 000
10846835008586 P990025 000
10846835008531 P990025 000
10846835008579 P990025 000
10846835008562 P990025 000
10846835008470 P990025 009
10846835008463 P990025 009
10846835003017 P990025 012
10846835003055 P990025 012
10846835002973 P990025 012
10846835003031 P990025 012
10846835002997 P990025 012

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.