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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceTHE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM
Generic NameTranscatheter septal occluder
ApplicantAbbott Medical
177 County Road B East
St. Paul, MN 55117
PMA NumberP000039
Date Received09/01/2000
Decision Date12/05/2001
Product Code MLV 
Docket Number 02M-0271
Notice Date 06/27/2002
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S035 S036 S058 S007 S006 S022 S023 S032 S038 S037 S005 
S016 S067 S054 S039 S041 S042 S043 S045 S046 S050 S051 S052 
S053 S055  S057 S047 S048 S049 S011 S012 S013 S015 S010 
S017 S018 S019 S030 S031 S056 S003 S004 S024 S025 S020 S026 
S001 S021 S027 S028 S029 S060 S061 S062 S064 S065 S066 S074 
S077 S079 S080 S072 S073 S063 S068 S069 S070 S071 S076 S075 
S082 S078 S081 
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