Reply SR and Reply DR Pacemakers

FDA Premarket Approval P950029 S124

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

To implement sterilization cycle microport01 at steris spa contactor

DeviceReply SR and Reply DR Pacemakers
Generic NameImplantable Pacemaker Pulse-generator
ApplicantMicroPort CRM USA Inc.
Date Received2020-02-10
Decision Date2020-03-06
PMAP950029
SupplementS124
Product CodeDXY 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002

Supplemental Filings

Supplement NumberDateSupplement Type
P950029Original Filing
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 0000-00-00
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

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