AMPLATZER MUSCULAR VSD OCCLUDER

Transcatheter Septal Occluder

FDA Premarket Approval P040040 S028

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

Addition of a new laser welding system.

DeviceAMPLATZER MUSCULAR VSD OCCLUDER
Classification NameTranscatheter Septal Occluder
Generic NameTranscatheter Septal Occluder
ApplicantAbbott Medical
Date Received2016-04-06
Decision Date2016-05-04
PMAP040040
SupplementS028
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
S045 2021-11-22 Real-time Process
S044 2021-06-28 30-day Notice
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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