Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator)

FDA Premarket Approval P060027 S102

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

DevicePlatinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator)
Generic NameDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
ApplicantMicroPort CRM USA Inc.
Date Received2020-02-10
Decision Date2020-03-06
PMAP060027
SupplementS102
Product CodeNIK 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002

Supplemental Filings

Supplement NumberDateSupplement Type
P060027Original Filing
S102 2020-02-10 30-day Notice
S101
S100 2019-11-15 30-day Notice
S099 2019-02-05 30-day Notice
S098 2018-12-20 Real-time Process
S097 2018-11-13 30-day Notice
S096 2018-04-19 30-day Notice
S095 2018-03-29 30-day Notice
S094 2018-02-26 30-day Notice
S093 2018-01-03 Real-time Process
S092 2018-01-03 30-day Notice
S091 2017-07-07 30-day Notice
S090 2017-05-22 Real-time Process
S089 2017-02-21 30-day Notice
S088 2016-12-19 Normal 180 Day Track
S087 2016-08-23 30-day Notice
S086 2016-08-23 30-day Notice
S085 2016-08-23 30-day Notice
S084 2016-08-09 Real-time Process
S083 2016-07-21 Real-time Process
S082 2016-07-14 30-day Notice
S081 2016-07-13 30-day Notice
S080 2015-11-17 135 Review Track For 30-day Notice
S079 2015-10-20 Normal 180 Day Track
S078 2015-07-07 30-day Notice
S077 2015-07-02 30-day Notice
S076 2015-07-01 30-day Notice
S075 2015-02-24 30-day Notice
S074 2015-02-19 30-day Notice
S073 2015-02-18 30-day Notice
S072 2015-02-11 Normal 180 Day Track
S071 2014-11-21 30-day Notice
S070 2014-10-01 Normal 180 Day Track No User Fee
S069 2014-09-15 Real-time Process
S068 2014-08-06 30-day Notice
S067 2014-06-20 30-day Notice
S066 2014-05-15 Normal 180 Day Track
S065 2014-04-24 Real-time Process
S064 2014-04-23 Real-time Process
S063 2014-04-10 30-day Notice
S062 2014-03-24 30-day Notice
S061 2014-03-18 Real-time Process
S060 2014-02-12 Real-time Process
S059 2014-01-29 30-day Notice
S058 2014-01-29 30-day Notice
S057 2013-10-31 30-day Notice
S056 2013-10-17 30-day Notice
S055 2013-09-11 30-day Notice
S054 2013-09-11 30-day Notice
S053 2013-08-21 Normal 180 Day Track
S052
S051 2013-07-15 30-day Notice
S050 2013-04-10 30-day Notice
S049 2013-02-25 30-day Notice
S048 2013-02-15 Real-time Process
S047 2013-02-11 30-day Notice
S046 2012-12-21 30-day Notice
S045 2012-07-31 30-day Notice
S044 2012-07-06 30-day Notice
S043 2012-07-05 30-day Notice
S042
S041 2012-05-16 30-day Notice
S040 2012-05-16 30-day Notice
S039 2012-03-23 30-day Notice
S038 2012-03-13 Normal 180 Day Track
S037 2012-01-27 30-day Notice
S036 2012-01-05 30-day Notice
S035 2011-12-12 30-day Notice
S034 2011-11-10 30-day Notice
S033 2011-10-31 30-day Notice
S032 2011-09-01 Normal 180 Day Track
S031 2011-06-06 30-day Notice
S030 2011-02-28 30-day Notice
S029 2010-12-16 Real-time Process
S028 2010-08-12 Real-time Process
S027 2010-07-16 Normal 180 Day Track No User Fee
S026 2010-06-28 Normal 180 Day Track
S025 2010-06-04 30-day Notice
S024 2010-05-17 Real-time Process
S023 2010-04-26 30-day Notice
S022 2010-03-30 30-day Notice
S021 2010-02-12 30-day Notice
S020 2010-02-05 30-day Notice
S019 2010-02-04 135 Review Track For 30-day Notice
S018
S017 2010-01-06 30-day Notice
S016 2009-11-16 30-day Notice
S015 2009-09-24 Normal 180 Day Track
S014 2009-04-09 30-day Notice
S013 2009-03-31 30-day Notice
S012 2009-03-04 30-day Notice
S011 2009-02-20 30-day Notice
S010 2009-01-28 30-day Notice
S009 2008-12-17 Normal 180 Day Track No User Fee
S008 2008-11-12 Real-time Process
S007 2008-11-10 135 Review Track For 30-day Notice
S006 2008-09-15 30-day Notice
S005 2008-08-21 Real-time Process
S004 2008-08-13 Normal 180 Day Track
S003 2008-06-23 Special (immediate Track)
S002 2008-06-13 Normal 180 Day Track No User Fee
S001 2008-06-10 Real-time Process

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