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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_20aa186f200a6c365e59b7820723f4d9. 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_20aa186f200a6c365e59b7820723f4d9

Brand Name

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

Device Class

Class D

Approving Authority

CDSCO

Product Information

Sinus-XL [In the Aorta abdominalis and straight section of the Aorta thorakalis descendens: โ€ข Insufficient outcome of angioplasty treatment โ€ข Residual stenosis following balloon angioplasty โ€ข Dissection โ€ข Elastic stenosis of bypass anastomoses โ€ข Vascular obliteration / Stenosis โ€ข Endoleak type 1a and 1b In straight sections of the vena cava: โ€ข Superior and inferior vena cava syndrome โ€ข Obstruction of the vena cava caused by malignant and benign tumours The safety and performance of the sinus-XL cannot be guaranteed under indications other than the above.]; Sinus-XL 6F [In the abdominal aorta and the straight section of the descending thoracic aorta: โ€ข Vascular occlusions / Stenosis โ€ข Dissection โ€ข Insufficient outcome of angioplasty treatment โ€ข Residual stenoses following balloon angioplasty โ€ข Elastic stenoses of bypass anastomoses โ€ข Endoleak type 1a and 1b In the vena cava: โ€ข Superior and inferior vena cava syndrome โ€ข Obstructions of the vena cava caused by malignant and benign tumors The safety and performance of the sinus-XL 6F cannot be guaranteed under indications other than the above.]

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