Identity
- Trade Name
- ENDOLOGIX POWERLINK SYSTEM FDA PMA
- Generic Name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT FDA PMA
Identifiers
- PMA Number
- P040002 FDA PMA
- FDA Product Code
- MIH FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Endologix PowerLink System is an endovascular graft designed for the treatment of abdominal aortic aneurysms (AAA). It is a bifurcated stent-graft system intended to exclude the aneurysm sac from blood flow while maintaining patency of the iliac arteries, thereby reducing the risk of aneurysm rupture.
The system is delivered via percutaneous or surgical cutdown access and is indicated for patients with suitable aneurysm morphology, including adequate iliac/femoral access (≥7 mm diameter), a non-aneurysmal aortic neck, and a minimum aortic length requirement. It is supplied as a Class III medical device with FDA_PMA approval and includes bifurcated models along with proximal cuff and limb extension accessories. The device is non-sterile and intended for single-use in a sterile field.
Frequently asked questions
What types of patients is the PowerLink System designed for, and what anatomical requirements must be met?
The PowerLink System is designed for patients with abdominal aortic aneurysms (AAA) who have suitable aneurysm morphology. Key anatomical requirements include adequate iliac/femoral access with a diameter of at least 7 mm, a non-aneurysmal aortic neck between the renal arteries and the aneurysm, and an aortic length that is at least 1.0 cm longer than the body portion of the chosen bifurcated model. The system also requires a common iliac artery distal fixation site for proper placement.
How is the PowerLink System delivered, and what types of access methods are compatible with it?
The PowerLink System is delivered via either percutaneous access (through the skin) or surgical cutdown (an open incision). Both methods allow for the deployment of the bifurcated stent-graft to treat AAA while maintaining blood flow through the iliac arteries. The choice of access depends on the patient’s anatomy and clinical context.
Is the PowerLink System sterile, and how should it be handled in the operating room?
The PowerLink System is **non-sterile** but is intended for **single-use in a sterile field**. This means it must be opened and prepared under sterile conditions, such as in a sterile tray or using sterile gloves and instruments, to ensure proper infection control during deployment.
What accessories are included with the PowerLink System, and how do they enhance its functionality?
The PowerLink System includes bifurcated models as well as **proximal cuff and limb extension accessories**. These accessories allow for customization of the graft to better fit the patient’s anatomy, ensuring proper sealing of the aneurysm sac and maintaining iliac artery patency. The cuffs and extensions help address variations in aortic neck size or iliac artery length.
What regulatory pathway was followed for the approval of the PowerLink System, and what does this mean for its use?
The PowerLink System underwent **FDA Pre-Market Approval (PMA)** through the **PMA number P040002**, confirming it meets stringent safety and effectiveness standards for Class III medical devices. This approval indicates that the device has been thoroughly evaluated for its intended use in treating abdominal aortic aneurysms in patients with specific anatomical criteria, ensuring compliance with U.S. regulatory requirements.
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 | P040002 | Class III | Active |
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Manufacturer
- Manufacturer
- Endologix LLC
- FDA Applicant
- Endologix, LLC
Sources (1)
- FDA PMA P040002 24 fields · synced Oct 6, 2026