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Protégé RX Self Expanding Peripheral Stent System颈动脉支架
| Brand | EV3（医伟司安） |
|---|---|
| Manufacturer | ev3, Inc.医伟司安股份有限公司 |
| Production Address | 4600 Nathan Lane North, Plymouth, MN,55442, United States |
| Intended Use | PROTÉGÉ™ RX Carotid Artery Stent, when used in conjunction with an embolic protection device, is indicated for percutaneous carotid artery revascularization in patients at high risk for adverse events following carotid endarterectomy, and who meet the following criteria:1.Patients with symptomatic stenosis of the common carotid artery or internal carotid artery (>50% by ultrasound or angiography), or asymptomatic patients with stenosis ≥80% by ultrasound or angiography.2. The reference vessel diameter at the target lesion site must be within the range of 4.5mm to 9.5mm.PROTÉGÉ™ RX颈动脉支架，当与栓塞保护装置配合使用时，适用于需要经皮颈动脉血运重建且存在颈动脉内膜剥脱术不良事件高风险，并且符合以下标准的患者：1. 患者颈总动脉或颈内动脉狭窄（症状性患者通过超声或血管造影> 50%，或无症状性患者通过超声或血管造影≥ 80%），且 2. 患者的靶病变处的参考血管直径必须在4.5mm到9.5mm的范围内 |
| References | SEPX-8-6-40 …… |
| Manufacturer’s Website | https://europe.medtronic.com/xd-en/healthcare-professionals/products/cardiovascular/peripheral-biliary-stents/protege-rx.html |
| Product Brochure | |
| Registration Certificate | 国械注进20163130715 |
Brand
This product consists of two parts: a self-expanding nickel-titanium memory alloy peripheral stent and a catheter delivery system. The stent is made of nickel-titanium alloy material (Nitinol) as required by ASTM F2063, and is available in straight and tapered types. The radiopaque material used for marking is tantalum metal. It is sterilized with ethylene oxide and is for single use only. The shelf life is 2 years.
该产品由自膨式镍钛记忆合金外周支架和导管输送系统两部分组成。支架选用ASTM F2063要求的镍钛合金材料（Nitinol）制成，分为直形和锥形两类，不透射线标记材料为钽金属。环氧乙烷灭菌，一次性使用。货架有效期2年
Products List
| REF | GTIN | Classification Code | Description |
|---|---|---|---|
| SEPX-10-20-135 | 00763000512019 | 13-07-02 | SEPX-10-20-135 颈动脉支架 |
| SEPX-10-30-135 | 00763000512026 | 13-07-02 | SEPX-10-30-135 颈动脉支架 |
| SEPX-10-40-135 | 00763000512033 | 13-07-02 | SEPX-10-40-135 颈动脉支架 |
| SEPX-10-60-135 | 00763000512040 | 13-07-02 | SEPX-10-60-135 颈动脉支架 |
| SEPX-10-7-30-135 | 00763000512057 | 13-07-02 | SEPX-10-7-30-135 颈动脉支架 |
| SEPX-10-7-40-135 | 00763000512064 | 13-07-02 | SEPX-10-7-40-135 颈动脉支架 |
| SEPX-6-20-135 | 00763000512071 | 13-07-02 | SEPX-6-20-135 颈动脉支架 |
| SEPX-6-30-135 | 00763000512088 | 13-07-02 | SEPX-6-30-135 颈动脉支架 |
| SEPX-6-40-135 | 00763000512095 | 13-07-02 | SEPX-6-40-135 颈动脉支架 |
| SEPX-6-60-135 | 00763000512101 | 13-07-02 | SEPX-6-60-135 颈动脉支架 |
| SEPX-7-20-135 | 00763000512118 | 13-07-02 | SEPX-7-20-135 颈动脉支架 |
| SEPX-7-30-135 | 00763000512125 | 13-07-02 | SEPX-7-30-135 颈动脉支架 |
| SEPX-7-40-135 | 00763000512132 | 13-07-02 | SEPX-7-40-135 颈动脉支架 |
| SEPX-7-60-135 | 00763000512149 | 13-07-02 | SEPX-7-60-135 颈动脉支架 |
| SEPX-8-20-135 | 00763000512156 | 13-07-02 | SEPX-8-20-135 颈动脉支架 |
| SEPX-8-30-135 | 00763000512163 | 13-07-02 | SEPX-8-30-135 颈动脉支架 |
| SEPX-8-40-135 | 00763000512170 | 13-07-02 | SEPX-8-40-135 颈动脉支架 |
| SEPX-8-60-135 | 00763000512200 | 13-07-02 | SEPX-8-60-135 颈动脉支架 |
| SEPX-8-6-30-135 | 00763000512187 | 13-07-02 | SEPX-8-6-30-135 颈动脉支架 |
| SEPX-8-6-40-135 | 00763000512194 | 13-07-02 | SEPX-8-6-40-135 颈动脉支架 |
| SEPX-9-20-135 | 00763000512217 | 13-07-02 | SEPX-9-20-135 颈动脉支架 |
| SEPX-9-30-135 | 00763000512224 | 13-07-02 | SEPX-9-30-135 颈动脉支架 |
| SEPX-9-40-135 | 00763000512231 | 13-07-02 | SEPX-9-40-135 颈动脉支架 |
| SEPX-9-60-135 | 00763000512248 | 13-07-02 | SEPX-9-60-135 颈动脉支架 |
| Risk-Based Classification风险管理类别 | |
|---|---|
| Product Status产品状态 | Active |
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