Protege RX Carotid Stent System; Protege GPS Self-Expanding Peripheral Stent System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS FDA PMA
- Generic Name
- Stent, carotid FDA PMA
Identifiers
- PMA Number
- P060001 FDA PMA
- FDA Product Code
- NIM FDA PMA
- Models / Variants
- Protege™ RX Carotid Stent System FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Protege RX Carotid Stent System and Protege GPS Self-Expanding Peripheral Stent System are self-expanding stents designed for percutaneous revascularization of carotid and peripheral arteries. These devices are intended for use in patients with carotid artery stenosis (≥50% symptomatic or ≥80% asymptomatic) or peripheral vessel diameters ranging from 4.5 mm to 9.5 mm at the target lesion, where surgical intervention carries higher risk.
These stent systems are supplied as Class III medical devices and are used in interventional radiology or vascular surgery settings. They are intended for single-use and must be handled under sterile conditions. The Protege RX system is approved for use in conjunction with EV3 embolic protection devices, while the Protege GPS system is indicated for peripheral artery applications. Regulatory authorisation is granted under FDA PMA (P060001) and includes multiple FEI numbers for tracking and compliance.
Frequently asked questions
What are the key differences between the Protege RX and Protege GPS stent systems in terms of their intended clinical use?
The Protege RX Carotid Stent System is specifically designed for percutaneous revascularization of carotid arteries in patients with stenosis (≥50% symptomatic or ≥80% asymptomatic) and is approved for use with EV3 embolic protection devices. In contrast, the Protege GPS Self-Expanding Peripheral Stent System targets peripheral arteries with vessel diameters ranging from 4.5 mm to 9.5 mm at the target lesion, intended for patients at high surgical risk who require revascularization in these regions.
Are these stent systems reusable, or are they intended for single-use only?
The Protege RX and Protege GPS stent systems are explicitly intended for single-use and must be handled under sterile conditions. Reuse is not recommended or supported by the manufacturer.
What vessel diameter range is suitable for the Protege GPS stent system, and how does this differ from the Protege RX?
The Protege GPS stent system is designed for peripheral arteries with a reference vessel diameter between 4.5 mm and 9.5 mm at the target lesion. The Protege RX, however, is focused on carotid arteries (common or internal) and does not specify a diameter range beyond the stenosis criteria (≥50% symptomatic or ≥80% asymptomatic). Both systems share the same vessel diameter upper limit of 9.5 mm, but the GPS is explicitly peripheral, while the RX is carotid-specific.
How should these stent systems be stored, and what precautions should be taken during handling?
Since the Protege RX and Protege GPS stent systems are intended for single-use and must be handled under sterile conditions, they should be stored in their original packaging until ready for use. The packaging is likely designed to maintain sterility, and any exposed components should be treated as sterile to prevent contamination before deployment.
What regulatory pathway was followed for FDA approval of these devices, and what does this mean for clinicians?
The Protege RX and Protege GPS stent systems were approved through the FDA Premarket Approval (PMA) pathway (PMA #P060001), which is the most stringent regulatory route for Class III medical devices. This means the devices underwent rigorous clinical trials and review to demonstrate safety and effectiveness before approval. Clinicians can rely on this approval for evidence-based use in high-risk patients with carotid or peripheral artery stenosis, as outlined in the FDA’s authorization criteria.
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 | P060001 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular, Inc.
Sources (1)
- FDA PMA P060001 24 fields · synced Oct 6, 2026