THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Transcatheter Septal Occluder

FDA Premarket Approval P000039

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the amplatzer septal occluder (aso) and the amplatzer exchange system. The amplatzer septal occluder (aso) device is indicated for the occlusion of atrial septal defects (asd) in secundum position. The aso device is also indicated in patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration. Patients indicated for asd closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (i. E. , 1. 5:1 degree of left to right shunt or rv enlargement). The amplatzer exchange system is intended for the removal of an amplatzer delivery sheath and subsequent exchange for an amplatzer delivery sheath of equal or larger diameter.

DeviceTHE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM
Classification NameTranscatheter Septal Occluder
Generic NameTranscatheter Septal Occluder
ApplicantAbbott Medical
Date Received2000-09-01
Decision Date2001-12-05
Notice Date2002-06-27
PMAP000039
SupplementS
Product CodeMLV
Docket Number02M-0271
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 5050 Nathan Lane North plymouth, MN 55442
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P000039Original Filing
S076 2021-11-22 Real-time Process
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
S071
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
S059
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
S044
S043 2011-12-29 Special (immediate Track)
S042 2011-09-20 30-day Notice
S041 2011-03-09 30-day Notice
S040
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
S034
S033
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)
S014
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
S009
S008
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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