Identity
- Trade Name
- XACT CAROTID STENT SYSTEM FDA PMA
- Generic Name
- Stent, carotid FDA PMA
Identifiers
- PMA Number
- P040038 FDA PMA
- FDA Product Code
- NIM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The XACT Transcarotid Stent System is a carotid stent designed to improve lumen diameter in carotid arteries. It is intended for percutaneous carotid angioplasty and stenting in patients with carotid artery stenosis who are at high risk for adverse events from carotid endarterectomy, with reference vessel diameters ranging between 4.8 mm and 9.1 mm.
This device is supplied as a reusable system for transcarotid delivery and has received FDA_PMA authorization. It is used in procedural settings where embolic protection is integrated with the stent system, adhering to strict regulatory standards for carotid intervention. The system is not described as single-use or MRI-safe in the provided data.
Frequently asked questions
What is the primary purpose of the XACT Transcarotid Stent System, and who is it intended for?
The XACT Transcarotid Stent System is designed to improve the lumen diameter in carotid arteries for patients with carotid artery stenosis who are at high surgical risk for carotid endarterectomy. It is specifically indicated for percutaneous carotid angioplasty and stenting in patients with reference vessel diameters between 4.8 mm and 9.1 mm, meeting criteria such as stenosis levels (≥50% symptomatic or ≥80% asymptomatic) and appropriate anatomical location.
Is the XACT Transcarotid Stent System reusable, and how is it supplied?
Yes, the XACT Transcarotid Stent System is supplied as a reusable system for transcarotid delivery. It is intended to be used in conjunction with an embolic protection system, meaning it is part of a comprehensive procedural setup rather than a single-use device.
What range of vessel diameters can the XACT Transcarotid Stent System accommodate?
The XACT Transcarotid Stent System is designed for reference vessel diameters ranging from 4.8 mm to 9.1 mm at the target lesion, ensuring compatibility with a variety of carotid artery sizes.
How was the regulatory approval for the XACT Transcarotid Stent System obtained, and what type of review process was involved?
The XACT Transcarotid Stent System received FDA_PMA (Premarket Approval) authorization, which is a rigorous review process for high-risk medical devices like stents. The approval was granted in 2005 after a thorough evaluation of clinical data and safety evidence, confirming its intended use for improving carotid artery lumen diameter in high-risk patients.
Does the XACT Transcarotid Stent System come with any specific embolic protection features?
Yes, the XACT Transcarotid Stent System is used in conjunction with Abbott Vascular’s embolic protection system, which is integrated to minimize the risk of debris embolization during the stenting procedure. This combination is essential for maintaining safety during percutaneous carotid interventions.
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. Sources consulted: Xact Carotid Stent System | Abbott, Xact Carotid Stent System | Abbott, XACT Carotid Stent System - P040038/S043 | FDA, XACT Transcarotid Stent System (XACT TSS) PMA P040038S045 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P040038 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular Inc.
- FDA Applicant
- Abbott Vascular, Inc.
Sources (1)
- FDA PMA P040038 24 fields · synced Sep 18, 2026