SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER

Implantable Pacemaker Pulse-generator

FDA Premarket Approval P950029 S024

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 the following software updates: 1) aaisafer ram patch 2. 3 for symphony dr 2550 devices with rom mask t3, 2) rom mask t4 for symphony dr 2550, symphony sr 2250, ela rhapsody+ dr 2530, ela rhapsody dr 2510, and ela rhapsody sr 2210, 3) elaview 1. 30 ug2 application software for the orchestra programmer.

DeviceSYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER
Classification NameImplantable Pacemaker Pulse-generator
Generic NameImplantable Pacemaker Pulse-generator
ApplicantMicroPort CRM USA Inc.
Date Received2005-07-05
Decision Date2005-09-02
PMAP950029
SupplementS024
Product CodeDXY
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002

Supplemental Filings

Supplement NumberDateSupplement Type
P950029Original 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

Device IDPMASupp
08031527009629 P950029 056
08031527012247 P950029 079
08031527011523 P950029 079
08031527009162 P950029 079
08031527009056 P950029 079
08031527013886 P950029 086
08031527019000 P950029 127
08031527019017 P950029 127
08031527019024 P950029 127
08031527019932 P950029 127
08031527009629 P950029 127
08031527018997 P950029 127

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