Identity
- Trade Name
- AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM FDA PMA
- Generic Name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS FDA PMA
Identifiers
- PMA Number
- P020024 FDA PMA
- FDA Product Code
- MAE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Amplatzer Duct Occluder is a percutaneous, transcatheter occlusion device classified as an Occluder, Patent Ductus, Arteriosus under FDA nomenclature. It is designed for the non-surgical closure of a patent ductus arteriosus (PDA), a congenital heart defect where the ductus arteriosus fails to close after birth.
This device is delivered via a 180-degree catheter system and is intended for use in interventional cardiology settings. It is supplied sterile and intended for single-use, with multiple sizes available for pediatric and adult patients. Approved under FDA_PMA (PMA Number: P020024), it adheres to Class III regulatory standards for cardiovascular devices.
Frequently asked questions
What is the Amplatzer Duct Occluder used for in clinical practice?
The Amplatzer Duct Occluder is designed specifically for the **non-surgical closure of a patent ductus arteriosus (PDA)**, a congenital heart defect where the ductus arteriosus remains open after birth. It is delivered percutaneously via a 180-degree catheter system in interventional cardiology settings, providing an alternative to surgical intervention for eligible patients.
How is the Amplatzer Duct Occluder supplied, and is it reusable?
The device is supplied **sterile** and is intended for **single-use only**. It comes in multiple sizes to accommodate pediatric and adult patients, ensuring compatibility with varying PDA dimensions. The sterile packaging ensures safety for one-time procedural use.
What regulatory pathway was followed for FDA approval of this device?
The Amplatzer Duct Occluder was approved under the **FDA’s Premarket Approval (PMA) pathway**, designated as a Class III device due to its cardiovascular indication. Approval was granted in 2003 (PMA Number: P020024) following a review by the FDA’s Cardiovascular Advisory Committee, confirming its safety and effectiveness for the intended use.
Are there different sizes available for the Amplatzer Duct Occluder, and how does this benefit patients?
Yes, the Amplatzer Duct Occluder is available in **multiple sizes** to accommodate both pediatric and adult patients with varying PDA dimensions. This modular approach allows clinicians to select the appropriate device size for optimal occlusion, reducing risks like residual shunting or device embolization.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P020024 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P020024 24 fields · synced Sep 18, 2026