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.
Addition of a rework process for components used in the smartview hotspot and the orchestra plus link peripheral devices.
Device | SMARTVIEW hotspot |
Classification Name | Implantable Pacemaker Pulse-generator |
Generic Name | Implantable Pacemaker Pulse-generator |
Applicant | MicroPort CRM USA Inc. |
Date Received | 2017-07-07 |
Decision Date | 2017-07-27 |
PMA | P950029 |
Supplement | S115 |
Product Code | DXY |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002 |
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 |
Device ID | PMA | Supp |
---|---|---|
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 |
Severity: Core Warning
Message: Module 'zip' already loaded
Filename: Unknown
Line Number: 0
Backtrace: