Identity
- Trade Name
- ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM FDA PMA
- Generic Name
- Stent, carotid FDA PMA
Identifiers
- PMA Number
- P040012 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 Rx Acculink Carotid Stent System is a carotid stent designed for the treatment of patients who require carotid revascularization. It is indicated for use in patients at high risk for adverse events from carotid endarterectomy who have specific levels of stenosis in the common or internal carotid artery.
This system is intended to be used in conjunction with Guidant carotid embolic protection systems. It is suitable for patients with a reference vessel diameter between 4.0 mm and 9.0 mm at the target lesion. The device has received FDA PMA authorization for clinical use.
Frequently asked questions
What is the primary indication for the Rx Acculink Carotid Stent System?
The system is indicated for carotid revascularization in patients who are at high risk for adverse events from carotid endarterectomy and meet specific stenosis criteria in the common or internal carotid artery.
Does the Rx Acculink Carotid Stent System require additional equipment?
Yes, the device is indicated for use in conjunction with Guidant carotid embolic protection systems to ensure proper procedural outcomes.
What vessel sizes is this stent designed to treat?
The Rx Acculink Carotid Stent System is indicated for patients who have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target 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 | P040012 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA PMA P040012 24 fields · synced Oct 6, 2026