Approval for the chorus rm model 7034 dddr pacemaker system and opus rm model 4534 ssir pacemaker system which includes an ibm compatible microcomputer which has been configured and furnished by ela medical, inc. With cso 2. 46 programming software and is connected to a cpr1 programming head. These devices are indicated for: rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation; and the generally accepted patient conditions warranting chronic cardiac pacing which include: *symptomatic paroxysmal or permanent second or third-degreee av block; *symptomatic bilateral bundle branch block; *symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; *bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and *vaso-vagal syndromes or hypersensitive carotid sinus syndromes. The chrous rm 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: *various degrees of av block to maintain the atrial contribution to cardiac output; and *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 | 1995-08-02 |
| Decision Date | 1997-03-10 |
| Notice Date | 1997-05-19 |
| PMA | P950029 |
| Supplement | S |
| Product Code | DXY |
| Docket Number | 97M-0185 |
| Advisory Committee | Cardiovascular |
| 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