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

FDA premarket approval P000039 · decided 2001-12-05

Approval details

PMA number

P000039

Trade name

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

Generic name

Transcatheter septal occluder

Applicant

ABBOTT MEDICAL

Date received

2000-09-01

Decision date

2001-12-05

Days to decision

460 days

Decision code

APPR

Product code

MLV

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

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 VENTRIC

510(k) clearances by this applicant