Amplatzer Septal Occluder

FDA Premarket Approval P000039 S075

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

The addition of a sterilization chamber (chamber 5) at the steris sterilization facility in costa rica

DeviceAmplatzer Septal Occluder
Generic NameTranscatheter Septal Occluder
ApplicantAbbott Medical
Date Received2021-08-24
Decision Date2021-09-22
Product CodeMLV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 5050 Nathan Lane North plymouth, MN 55442

Supplemental Filings

Supplement NumberDateSupplement Type
P000039Original Filing
S075 2021-08-24 30-day Notice
S074 2021-06-28 30-day Notice
S073 2020-05-06 30-day Notice
S072 2020-04-24 30-day Notice
S070 2020-03-19 30-day Notice
S069 2020-03-17 30-day Notice
S068 2019-09-26 30-day Notice
S067 2019-06-24 Normal 180 Day Track No User Fee
S066 2019-03-22 30-day Notice
S065 2019-02-27 30-day Notice
S064 2019-02-15 Normal 180 Day Track No User Fee
S063 2019-01-03 30-day Notice
S062 2018-02-12 30-day Notice
S061 2017-11-28 30-day Notice
S060 2017-10-30 Normal 180 Day Track No User Fee
S058 2017-07-06 30-day Notice
S057 2017-01-26 30-day Notice
S056 2016-07-01 30-day Notice
S055 2016-04-06 30-day Notice
S054 2016-03-14 30-day Notice
S053 2015-10-30 Normal 180 Day Track No User Fee
S052 2015-08-21 Normal 180 Day Track No User Fee
S051 2015-08-10 Normal 180 Day Track No User Fee
S050 2015-03-13 Normal 180 Day Track No User Fee
S049 2013-02-19 135 Review Track For 30-day Notice
S048 2013-02-06 Normal 180 Day Track
S047 2012-11-30 Special (immediate Track)
S046 2012-05-14 30-day Notice
S045 2012-04-24 30-day Notice
S043 2011-12-29 Special (immediate Track)
S042 2011-09-20 30-day Notice
S041 2011-03-09 30-day Notice
S039 2011-01-19 30-day Notice
S038 2010-11-15 30-day Notice
S037 2010-11-12 Normal 180 Day Track No User Fee
S036 2010-04-21 30-day Notice
S035 2010-03-11 30-day Notice
S032 2009-09-01 Special (immediate Track)
S031 2009-03-31 Normal 180 Day Track No User Fee
S030 2009-03-12 30-day Notice
S029 2009-02-11 Real-time Process
S028 2008-12-23 30-day Notice
S027 2008-12-09 Special (immediate Track)
S026 2008-02-25 135 Review Track For 30-day Notice
S025 2008-02-04 30-day Notice
S024 2008-01-28 30-day Notice
S023 2007-07-10 135 Review Track For 30-day Notice
S022 2007-05-23 135 Review Track For 30-day Notice
S021 2007-02-23 Normal 180 Day Track
S020 2006-11-07 Real-time Process
S019 2006-09-01 Normal 180 Day Track No User Fee
S018 2006-08-29 Normal 180 Day Track No User Fee
S017 2006-08-22 30-day Notice
S016 2006-06-21 30-day Notice
S015 2006-01-23 Special (immediate Track)
S013 2005-11-21 Normal 180 Day Track
S012 2005-11-14 Normal 180 Day Track
S011 2005-11-16 Real-time Process
S010 2005-07-21 Real-time Process
S007 2004-02-02 30-day Notice
S006 2003-07-22 30-day Notice
S005 2003-04-15 30-day Notice
S004 2003-01-24 30-day Notice
S003 2002-12-16 30-day Notice
S002 2002-03-12 Special (immediate Track)
S001 2002-01-28 Normal 180 Day Track

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