Approval for functional changes to reduce size and update algorithms and features in previously approved chorus rm model 7034 and opus rm model 4534. The device, as modified, will be marketed under the trade name brio and is indicated for: the generally accepted patient conditions warranting chronic cardiac pacing which include: 1) symptomatic paroxysmal or permanent second or third-degree av block; 2) symptomatic bilateral bundle branch block; 3) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conductions disorders; 4) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomaitc tachyarrhythmias; and 5) vaso-vagal syndrome or hypersensitive carotid sinus syndromes. The brio is also indicated for dual-chamber and atrial tracking modes in patients who may benefit from maintenance of av synchrony. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and av synchrony which include: 1) various degrees of av block to maintain the atrial contribution to cardiac output; and 2) vvi intolerance (e. G. , pacemaker syndrome) in the presence of persistent sinus rhythm.
| Device | CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | MicroPort CRM USA Inc. |
| Date Received | 1998-08-04 |
| Decision Date | 1998-12-22 |
| PMA | P950029 |
| Supplement | S001 |
| Product Code | DXY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P950029 | | Original Filing |
| S131 |
2021-02-09 |
30-day Notice |
| S130 | | |
| S129 | | |
| S128 |
2020-09-24 |
30-day Notice |
| S127 | | |
| S126 |
2020-07-13 |
30-day Notice |
| S125 |
2020-02-27 |
30-day Notice |
| S124 |
2020-02-10 |
30-day Notice |
| S123 |
2019-07-01 |
30-day Notice |
| S122 |
2018-04-19 |
30-day Notice |
| S121 |
2018-03-29 |
30-day Notice |
| S120 |
2018-02-16 |
30-day Notice |
| S119 |
2018-01-05 |
30-day Notice |
| S118 |
2018-01-03 |
Real-time Process |
| S117 |
2018-01-03 |
30-day Notice |
| S116 |
2017-08-15 |
30-day Notice |
| S115 |
2017-07-07 |
30-day Notice |
| S114 |
2017-07-07 |
30-day Notice |
| S113 |
2016-10-06 |
Real-time Process |
| S112 |
2016-10-01 |
30-day Notice |
| S111 |
2016-07-21 |
Real-time Process |
| S110 |
2016-05-27 |
30-day Notice |
| S109 |
2016-02-08 |
30-day Notice |
| S108 |
2015-11-17 |
135 Review Track For 30-day Notice |
| S107 |
2015-07-07 |
30-day Notice |
| S106 |
2015-07-01 |
30-day Notice |
| S105 |
2015-03-30 |
Normal 180 Day Track |
| S104 |
2015-02-24 |
30-day Notice |
| S103 |
2015-02-18 |
30-day Notice |
| S102 |
2015-02-11 |
Normal 180 Day Track |
| S101 |
2014-12-08 |
Special (immediate Track) |
| S100 |
2014-11-21 |
30-day Notice |
| S099 |
2014-11-17 |
Real-time Process |
| S098 |
2014-10-01 |
Normal 180 Day Track No User Fee |
| S097 |
2014-10-01 |
Special (immediate Track) |
| S096 |
2014-10-09 |
Real-time Process |
| S095 |
2014-08-08 |
30-day Notice |
| S094 |
2014-08-06 |
30-day Notice |
| S093 |
2014-07-21 |
30-day Notice |
| S092 |
2014-07-17 |
30-day Notice |
| S091 |
2014-06-20 |
30-day Notice |
| S090 |
2014-04-10 |
30-day Notice |
| S089 |
2014-02-21 |
30-day Notice |
| S088 |
2014-02-12 |
Real-time Process |
| S087 |
2014-01-29 |
30-day Notice |
| S086 |
2014-01-10 |
Real-time Process |
| S085 |
2013-10-31 |
30-day Notice |
| S084 |
2013-09-11 |
30-day Notice |
| S083 |
2013-09-11 |
30-day Notice |
| S082 |
2013-08-02 |
30-day Notice |
| S081 | | |
| S080 |
2013-07-15 |
30-day Notice |
| S079 |
2013-04-30 |
Normal 180 Day Track |
| S078 |
2013-02-25 |
30-day Notice |
| S077 |
2013-02-19 |
30-day Notice |
| S076 |
2013-02-19 |
30-day Notice |
| S075 |
2013-02-19 |
Special (immediate Track) |
| S074 |
2013-02-11 |
30-day Notice |
| S073 |
2013-01-24 |
Real-time Process |
| S072 |
2012-10-25 |
Real-time Process |
| S071 |
2012-07-31 |
30-day Notice |
| S070 |
2012-07-06 |
30-day Notice |
| S069 |
2012-07-05 |
30-day Notice |
| S068 |
2012-05-16 |
30-day Notice |
| S067 |
2012-03-23 |
30-day Notice |
| S066 |
2012-01-27 |
30-day Notice |
| S065 |
2012-01-05 |
30-day Notice |
| S064 |
2011-10-26 |
30-day Notice |
| S063 | | |
| S062 |
2011-08-04 |
30-day Notice |
| S061 |
2011-08-03 |
30-day Notice |
| S060 |
2011-06-24 |
Real-time Process |
| S059 | | |
| S058 |
2011-03-15 |
30-day Notice |
| S057 |
2011-01-31 |
30-day Notice |
| S056 |
2011-01-27 |
Real-time Process |
| S055 |
2010-11-03 |
30-day Notice |
| S054 |
2010-07-19 |
Special (immediate Track) |
| S053 |
2010-05-17 |
Real-time Process |
| S052 |
2010-04-26 |
30-day Notice |
| S051 |
2010-02-12 |
30-day Notice |
| S050 |
2010-01-06 |
30-day Notice |
| S049 |
2009-11-04 |
Real-time Process |
| S048 |
2009-11-04 |
Real-time Process |
| S047 |
2009-09-28 |
30-day Notice |
| S046 |
2009-06-17 |
Special (immediate Track) |
| S045 |
2009-07-06 |
30-day Notice |
| S044 |
2009-03-31 |
30-day Notice |
| S043 |
2009-03-04 |
30-day Notice |
| S042 |
2009-03-04 |
Special (immediate Track) |
| S041 |
2009-03-02 |
Normal 180 Day Track |
| S040 |
2009-01-28 |
30-day Notice |
| S039 |
2008-11-12 |
Real-time Process |
| S038 |
2008-09-15 |
30-day Notice |
| S037 |
2008-06-23 |
Special (immediate Track) |
| S036 |
2008-06-10 |
Real-time Process |
| S035 | | |
| S034 |
2008-03-05 |
Real-time Process |
| S033 |
2008-01-14 |
Special (immediate Track) |
| S032 |
2007-11-09 |
Normal 180 Day Track |
| S031 |
2007-08-29 |
Real-time Process |
| S030 |
2007-01-24 |
Normal 180 Day Track |
| S029 |
2006-08-28 |
Real-time Process |
| S028 |
2006-08-18 |
30-day Notice |
| S027 |
2006-08-18 |
30-day Notice |
| S026 |
2006-07-11 |
Real-time Process |
| S025 |
2006-01-30 |
Real-time Process |
| S024 |
2005-07-05 |
Real-time Process |
| S023 |
2005-01-31 |
30-day Notice |
| S022 |
2004-11-16 |
Normal 180 Day Track |
| S021 |
2004-10-07 |
Special (immediate Track) |
| S020 |
2004-06-07 |
Real-time Process |
| S019 |
2003-12-04 |
Real-time Process |
| S018 | | |
| S017 |
2002-12-23 |
Normal 180 Day Track |
| S016 |
2002-07-11 |
Normal 180 Day Track |
| S015 |
2001-10-31 |
Real-time Process |
| S014 |
2001-01-04 |
Normal 180 Day Track |
| S013 |
2001-01-11 |
Real-time Process |
| S012 |
2000-08-14 |
Real-time Process |
| S011 |
2000-08-18 |
Real-time Process |
| S010 |
2000-09-27 |
Real-time Process |
| S009 |
1999-10-12 |
Real-time Process |
| S008 |
1999-09-16 |
Normal 180 Day Track |
| S007 |
1999-08-26 |
Real-time Process |
| S006 |
1999-08-23 |
Normal 180 Day Track |
| S005 |
1999-02-26 |
Normal 180 Day Track |
| S004 | | |
| S003 |
1998-09-10 |
Normal 180 Day Track |
| S002 |
1998-08-31 |
Real-time Process |
| S001 |
1998-08-04 |
Normal 180 Day Track |
NIH GUDID Devices