Absolute Pro Vascular Self-Expanding Stent System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM FDA PMA
- Generic Name
- STENT, ILIAC FDA PMA
Identifiers
- PMA Number
- P110028 FDA PMA
- FDA Product Code
- NIO FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Absolute Pro Vascular Self-Expanding Stent System is a medical device designed to improve luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery. The device is indicated for use in vessels with reference diameters between 4.3 mm and 9.1 mm and lesion lengths up to 90 mm.
The device is supplied as a sterile, single-use system. It is intended for use by trained medical professionals in a clinical setting. The device is regulated as a Class III medical device and has received approval from the FDA under a Premarket Approval (PMA) application.
Frequently asked questions
What is the Absolute Pro Vascular Self-Expanding Stent System used for?
The device is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery. It is specifically designed for vessels with reference diameters between 4.3 mm and 9.1 mm and lesion lengths up to 90 mm.
Is the Absolute Pro Vascular Self-Expanding Stent System reusable?
No, the device is supplied as a sterile, single-use system. This means it is intended for one-time use on a single patient and should not be resterilized or reused.
What is the regulatory status of the Absolute Pro Vascular Self-Expanding Stent System?
The device is regulated as a Class III medical device. It has received approval from the FDA under a Premarket Approval (PMA) application, which is a rigorous process to demonstrate the safety and effectiveness of the device.
What are the size specifications for the Absolute Pro Vascular Self-Expanding Stent System?
The device is indicated for use in vessels with reference diameters between 4.3 mm and 9.1 mm and lesion lengths up to 90 mm. The specific size of the stent used will be determined by the treating physician based on the patient's anatomy and the characteristics of the lesion.
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 | P110028 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular Inc.
- FDA Applicant
- Abbott Vascular, Inc.
Sources (1)
- FDA PMA P110028 24 fields · synced Sep 18, 2026