Amplatzer Duct Occluder and 180 Degree Delivery System

FDA premarket approval P020024 · Occluder, Patent Ductus, Arteriosus

PMA numberP020024

Approval

Applicant
Abbott Medical
Received
June 24, 2002
Decision date
May 14, 2003 (APPR)
Supplements
65, latest May 28, 2026
Product code
MAE – Occluder, Patent Ductus, Arteriosus

Official FDA PMA record

Approval order statement

APPROVAL FOR THE AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM. THE PERCUTANEOUS, TRANSCATHETER OCCLUSION DEVICE IS INDICATED FOR THE NON-SURGICAL CLOSURE OF PATENT DUCTUS ARTERIOSUS (PDA).