This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the phylax av icd system including the pulse generator, model number 122 382 and phylax av software cartridge swm 1000/i-gav. 2. U, model number 128 814. The device is indicated for use in patients who are at high risk of sudden death due to ventricular arrhythmias and have experienced one or more of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by a loss of consciousness due to a ventricular tachyarrhythmia 2) recurrent, poorly tolerated sustained ventricular tachycardia (vt) note: the clinical outcome for hemodynamically stable, sustained-vt patients id not fully known. Safety and effectiveness studies for this indication have not been conducted.
| Device | PHYLAX AV ICD SYSTEM |
| Classification Name | Defibrillator, Implantable, Dual-chamber |
| Generic Name | Defibrillator, Implantable, Dual-chamber |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2000-02-14 |
| Decision Date | 2000-09-29 |
| Notice Date | 2001-01-23 |
| PMA | P000009 |
| Supplement | S |
| Product Code | MRM |
| Docket Number | 01M-0042 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000009 | Original Filing | |
| S100 | 2022-11-15 | Real-time Process |
| S099 | 2022-11-10 | 30-day Notice |
| S098 | 2022-06-17 | 30-day Notice |
| S097 | 2022-02-07 | Real-time Process |
| S096 | ||
| S095 | ||
| S094 | 2021-07-21 | 30-day Notice |
| S093 | 2021-06-21 | 30-day Notice |
| S092 | ||
| S091 | 2021-05-05 | 30-day Notice |
| S090 | 2021-03-16 | Real-time Process |
| S089 | 2020-11-23 | 30-day Notice |
| S088 | 2020-11-02 | 30-day Notice |
| S087 | 2020-08-10 | Real-time Process |
| S086 | ||
| S085 | 2020-03-26 | 30-day Notice |
| S084 | ||
| S083 | ||
| S082 | ||
| S081 | 2019-08-15 | Real-time Process |
| S080 | 2019-07-01 | Real-time Process |
| S079 | 2019-03-11 | Real-time Process |
| S078 | 2018-09-12 | Normal 180 Day Track |
| S077 | 2018-08-22 | Real-time Process |
| S076 | 2018-05-17 | Real-time Process |
| S075 | 2017-10-18 | Real-time Process |
| S074 | 2017-06-06 | Real-time Process |
| S073 | ||
| S072 | 2017-04-20 | Real-time Process |
| S071 | 2017-02-16 | Normal 180 Day Track |
| S070 | 2016-12-07 | Normal 180 Day Track |
| S069 | 2016-08-08 | Normal 180 Day Track |
| S068 | 2016-07-28 | Normal 180 Day Track |
| S067 | 2016-06-06 | Normal 180 Day Track |
| S066 | 2016-03-24 | Real-time Process |
| S065 | 2015-12-23 | Normal 180 Day Track |
| S064 | 2015-12-16 | Real-time Process |
| S063 | 2015-04-16 | Normal 180 Day Track |
| S062 | 2015-03-23 | Normal 180 Day Track |
| S061 | 2015-02-13 | Real-time Process |
| S060 | 2014-09-25 | Normal 180 Day Track |
| S059 | 2014-09-24 | 30-day Notice |
| S058 | 2014-06-23 | Normal 180 Day Track |
| S057 | 2013-11-25 | Normal 180 Day Track |
| S056 | 2013-11-07 | Real-time Process |
| S055 | 2013-08-15 | Real-time Process |
| S054 | 2013-04-03 | Real-time Process |
| S053 | ||
| S052 | 2012-12-21 | Real-time Process |
| S051 | 2012-12-18 | Normal 180 Day Track |
| S050 | 2012-07-02 | Real-time Process |
| S049 | 2012-03-01 | Normal 180 Day Track |
| S048 | 2012-02-17 | Real-time Process |
| S047 | 2011-11-02 | Normal 180 Day Track |
| S046 | 2011-08-19 | Normal 180 Day Track |
| S045 | 2011-04-11 | Real-time Process |
| S044 | ||
| S043 | 2010-12-13 | Real-time Process |
| S042 | 2010-10-28 | Normal 180 Day Track |
| S041 | 2010-08-20 | 30-day Notice |
| S040 | 2010-06-08 | Normal 180 Day Track |
| S039 | 2010-05-28 | Normal 180 Day Track No User Fee |
| S038 | 2009-11-25 | Real-time Process |
| S037 | ||
| S036 | 2009-09-10 | Real-time Process |
| S035 | 2009-07-08 | Normal 180 Day Track |
| S034 | 2009-02-13 | Real-time Process |
| S033 | 2009-01-26 | Normal 180 Day Track |
| S032 | 2008-11-17 | Normal 180 Day Track |
| S031 | 2008-10-31 | Real-time Process |
| S030 | 2008-09-25 | 135 Review Track For 30-day Notice |
| S029 | 2008-07-03 | 135 Review Track For 30-day Notice |
| S028 | 2008-05-21 | Real-time Process |
| S027 | ||
| S026 | 2008-05-14 | Normal 180 Day Track |
| S025 | 2008-01-15 | Real-time Process |
| S024 | 2007-10-26 | Normal 180 Day Track |
| S023 | 2007-08-13 | Normal 180 Day Track |
| S022 | 2007-07-13 | Normal 180 Day Track |
| S021 | 2006-10-12 | Real-time Process |
| S020 | 2006-09-11 | Normal 180 Day Track |
| S019 | 2006-06-29 | Real-time Process |
| S018 | 2006-04-10 | 135 Review Track For 30-day Notice |
| S017 | 2006-03-10 | Real-time Process |
| S016 | 2005-06-16 | Real-time Process |
| S015 | 2005-03-18 | Real-time Process |
| S014 | 2005-01-24 | Real-time Process |
| S013 | 2004-08-27 | Real-time Process |
| S012 | 2004-04-12 | Real-time Process |
| S011 | 2004-03-03 | Real-time Process |
| S010 | 2003-09-29 | Real-time Process |
| S009 | 2003-07-03 | Normal 180 Day Track |
| S008 | 2003-02-10 | Normal 180 Day Track |
| S007 | 2002-12-19 | Normal 180 Day Track |
| S006 | 2002-11-20 | 30-day Notice |
| S005 | 2002-09-25 | Real-time Process |
| S004 | 2002-03-22 | Panel Track |
| S003 | 2002-01-18 | Real-time Process |
| S002 | 2001-08-10 | Real-time Process |
| S001 | 2000-12-13 | Normal 180 Day Track |