Occlutech ASD Occluder and Occlutech Pistol Pusher
PMA P200032
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP200032 | Date29 Dec 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Transcatheter septal occluder (atrial)
- PMA Number
- FDA Product Code
- OZG
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Occlutech ASD Occluder is a transcatheter septal occluder (atrial) designed for the percutaneous closure of ostium secundum-type atrial septal defects (ASD). It is intended for patients with echocardiographic evidence of ostium secundum ASD and clinical signs of right ventricular volume overload, such as a hemodynamically significant left-to-right shunt or right ventricular enlargement. The device functions by occluding the defect via a self-expanding, dual-disc mechanism, restoring normal blood flow between the atria. Its delivery system, the Occlutech Pistol Pusher, facilitates precise placement through a catheter-based approach.
The Occlutech ASD Occluder and Pistol Pusher are supplied as a sterile, single-use system for interventional cardiology procedures. The device is intended for use in MRI-unsafe environments due to its metallic components and must be handled in accordance with sterile technique. Sizes are tailored to patient anatomy, with specific diameters and delivery system compatibility detailed in the accompanying instructions. Authorized for use under FDA Premarket Approval (PMA P200032), the system adheres to Class III regulatory standards for transcatheter cardiac devices.
Questions
AI-generated answers, 18 Sep 2026
What types of atrial septal defects (ASDs) is the Occlutech ASD Occluder designed to treat, and how does it work?
The Occlutech ASD Occluder is specifically designed for **ostium secundum-type ASDs**, which are a common form of ASD where the defect occurs in the central portion of the atrial septum. It works by using a **self-expanding, dual-disc mechanism** that spans the defect, effectively sealing it off and restoring normal blood flow between the left and right atria. This reduces the left-to-right shunt and alleviates symptoms like right ventricular volume overload, which is often seen in patients with hemodynamically significant shunts or RV enlargement.
Is the Occlutech ASD Occluder system single-use, and if so, how should it be handled to maintain sterility?
Yes, the Occlutech ASD Occluder and its delivery system, the Occlutech Pistol Pusher, are **sterile and intended for single-use only**. To maintain sterility, the system must be handled using **aseptic techniques** during the procedure, as it is supplied pre-sterilized and packaged for interventional cardiology use. Any breach of sterility could compromise the safety and effectiveness of the device.
Can this device be used in patients who will require MRI scans in the future, and why?
No, the Occlutech ASD Occluder is **not MRI-safe** due to its metallic components. The device contains materials that could generate significant heat or cause other adverse effects in a magnetic resonance imaging environment. Patients with this device implanted should avoid MRI scans unless specifically cleared by their physician, as the risks outweigh any potential benefits in most cases.
How are the sizes of the Occlutech ASD Occluder determined, and what factors influence the selection?
The sizes of the Occlutech ASD Occluder are **tailored to the patient’s anatomy**, specifically the dimensions of their ostium secundum ASD. Selection is based on **echocardiographic measurements** of the defect, ensuring proper sizing for effective occlusion. The accompanying instructions provide detailed guidance on compatible delivery system sizes and sizing charts to match the patient’s anatomy, which is critical for successful deployment and long-term durability.
What regulatory pathway was followed for FDA approval of this device, and what does that mean for clinicians?
The Occlutech ASD Occluder received **FDA Premarket Approval (PMA P200032)**, which is the highest level of regulatory review for medical devices in the U.S. This approval confirms that the device meets rigorous standards for safety and effectiveness as a **Class III transcatheter cardiac device**, particularly for the closure of ostium secundum ASDs in patients with echocardiographic and clinical evidence of right ventricular volume overload. Clinicians can rely on this approval as evidence of the device’s validated performance and compliance with FDA requirements.