Amplatzer Muscular VSD Occluder

FDA Premarket Approval P040040 S043

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

Implementation of parametric release as part of the sterilization process at the midwestern sterilization corporation facility

DeviceAmplatzer Muscular VSD Occluder
Generic NameTranscatheter Septal Occluder
ApplicantAbbott Medical
Date Received2020-05-06
Decision Date2020-06-04
PMAP040040
SupplementS043
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
P040040Original Filing
S043 2020-05-06 30-day Notice
S042 2020-04-24 30-day Notice
S041
S040 2020-03-19 30-day Notice
S039 2020-03-17 30-day Notice
S038 2019-09-26 30-day Notice
S037 2019-06-24 Normal 180 Day Track No User Fee
S036 2019-02-27 30-day Notice
S035 2019-02-15 Normal 180 Day Track No User Fee
S034 2019-01-03 30-day Notice
S033 2018-02-12 30-day Notice
S032
S031 2017-07-06 30-day Notice
S030 2017-01-26 30-day Notice
S029 2016-07-01 30-day Notice
S028 2016-04-06 30-day Notice
S027 2016-03-14 30-day Notice
S026 2016-01-19 Normal 180 Day Track No User Fee
S025 2015-10-30 Normal 180 Day Track No User Fee
S024 2015-08-21 Normal 180 Day Track No User Fee
S023 2013-02-19 135 Review Track For 30-day Notice
S022 2013-02-06 Normal 180 Day Track
S021 2012-05-14 30-day Notice
S020 2012-04-24 30-day Notice
S019 2011-09-20 30-day Notice
S018 2011-03-09 30-day Notice
S017
S016 2011-01-19 30-day Notice
S015 2010-11-15 30-day Notice
S014 2010-06-09 Normal 180 Day Track No User Fee
S013 2010-04-21 30-day Notice
S012 2010-03-11 30-day Notice
S011
S010
S009 2009-02-11 Real-time Process
S008 2008-12-23 30-day Notice
S007 2008-12-09 Special (immediate Track)
S006 2008-11-28 Normal 180 Day Track No User Fee
S005 2008-02-25 135 Review Track For 30-day Notice
S004 2008-02-04 30-day Notice
S003 2008-01-28 30-day Notice
S002 2007-12-14 30-day Notice
S001 2007-11-06 30-day Notice

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