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.
Approval for expanded indications for use for the 6 fr and 7 fr cordis webster diagnostic/ablation deflectable tip catheters and interface cables. In addition to the previously approved indications for interruption of accessory av conduction pathways associated with tachycardia, the treatment of av nodal reentrant tachycardia (avnrt), and creation of complete av nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia, your ablation system is now approved to treat patients with the following indications for use: 1) pediatric patients (age 4 years or older); 2) patients with persistent junctional reciprocating tachycardia (pjrt); and 3) patients with mahaim fibers.
Device | CORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR |
Classification Name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
Generic Name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
Applicant | Biosense Webster, Inc |
Date Received | 1998-07-27 |
Decision Date | 1999-01-26 |
PMA | P950005 |
Supplement | S003 |
Product Code | DRF |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | Biosense Webster, Inc 33 Technology Dr. irvine, CA 92618 |
Supplement Number | Date | Supplement Type |
---|---|---|
P950005 | Original Filing | |
S085 | 2022-09-02 | 30-day Notice |
S084 | 2022-06-10 | Normal 180 Day Track |
S083 | 2021-08-23 | Normal 180 Day Track No User Fee |
S082 | ||
S081 | 2021-06-11 | 30-day Notice |
S080 | ||
S079 | 2021-04-12 | 30-day Notice |
S078 | 2021-03-31 | 30-day Notice |
S077 | 2021-03-02 | Special (immediate Track) |
S076 | 2021-01-28 | 30-day Notice |
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 |