The Amplatzer(R) Septal Occluder (Aso) and the Amplatzer Exchange System

FDA premarket approval P000039 · Transcatheter septal occluder

PMA numberP000039

Approval

Applicant
Abbott Medical
Received
September 1, 2000
Decision date
December 5, 2001 (APPR)
Supplements
76, latest May 28, 2026
Product code
MLV – Transcatheter Septal Occluder

Official FDA PMA record

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.