Self-expanding Vascular Stent System - India CDSCO Medical Device Registration

Self-expanding Vascular Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000692_9822342b079f4c23e558f6bd01e6774a_59a8de92611a6acba2444b63436c4c24. This device is marketed under the brand name sinus-XL [sinus-XL, sinus-XL 6F]. The license holder is NovoMed Incorporation Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Self-expanding Vascular Stent System

UID: IMP/MD/2021/000692_9822342b079f4c23e558f6bd01e6774a_59a8de92611a6acba2444b63436c4c24

Brand Name

sinus-XL [sinus-XL, sinus-XL 6F]

License Holder

NovoMed Incorporation Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

In the abdominal aorta and the descending aorta: • Aortic coarctations • Vascular occlusions / Stenoses • Insufficient outcome of angioplasty treatment • Dissection • Residual stenoses following balloon angioplasty • Elastic stenoses of bypass anastomoses • Endoleak type 1a and 1b In the vena cava: • Superior and inferior vena cava syndrome • Obstructions of the vena cava caused by malignant and benign tumors In the iliofemoral veins: • Symptomatic obstructions The safety and performance of the sinus-XL Flex cannot be guaranteed under indications other than the above.