AMPLATZER Duct Occluder II Clinical Study

Inclusion Criteria:

- Subject must have diagnosis of a PDA

- Subject must have a PDA < 5.5mm in diameter by angiography

- Subject must have a PDA < 12mm in length by angiography

- Subject must have a PDA > 3mm in length by angiography

- Subject/legally authorized representative must give consent to participate in the
clinical study

- Subject/legally authorized representative must consent to follow-up for the duration
of the clinical study

Exclusion Criteria:

- Subject must not be < 6 kilograms for the procedure

- Subject must not be < 6 months of age

- Subject must not be ≥ 18 years of age

- Subject must not have a descending aorta < 10mm in diameter

- Subject must not have a right to left shunt through the patent ductus arteriosus

- Subject must not have PVR above 8 Woods units or a Rp/Rs >0.4

- Subject must not have intracardiac thrombus

- Subject must not have additional cardiac anomalies requiring surgical or
interventional correction

- Subject must not have history of more than two lower respiratory infections within the
last year (i.e., pneumonia)

- Subject must not have active infection requiring treatment at the time of implant

- Subject must not have contraindication to anticoagulation treatment

- Female subjects of child bearing age must not be pregnant or desire to become pregnant
within six months post implant*

- Subject must not be participating in another study for an investigational drug and/or
device that may clinically interfere with this study's endpoints

- If the subject desires to become pregnant after six months post-implant, further
restriction is at the discretion of their physician.