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Device | THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM |
Generic Name | Transcatheter septal occluder |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P000039 |
Date Received | 09/01/2000 |
Decision Date | 12/05/2001 |
Product Code |
MLV |
Docket Number | 02M-0271 |
Notice Date | 06/27/2002 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Recalls | CDRH 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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show 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 |