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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Brand Name
sinus-XL [sinus-XL, sinus-XL 6F]
License Holder
NovoMed Incorporation Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
Sinus-XL [In the Aorta abdominalis and straight section of the Aorta thorakalis descendens: โข Insufficient outcome of angioplasty treatment โข Residual stenosis following balloon angioplasty โข Dissection โข Elastic stenosis of bypass anastomoses โข Vascular obliteration / Stenosis โข Endoleak type 1a and 1b In straight sections of the vena cava: โข Superior and inferior vena cava syndrome โข 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: โข Vascular occlusions / Stenosis โข Dissection โข Insufficient outcome of angioplasty treatment โข Residual stenoses following balloon angioplasty โข Elastic stenoses of bypass anastomoses โข Endoleak type 1a and 1b In the vena cava: โข Superior and inferior vena cava syndrome โข 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.]
Self-expanding Vascular Stent System
Brand: sinus-Obliquus
NovoMed Incorporation Pvt. Ltd.
Self-expanding Vascular Stent System
Brand: sinus-XL [sinus-XL, sinus-XL 6F]
NovoMed Incorporation Pvt. Ltd.
Self-expanding Vascular Stent System
Brand: sinus-Obliquus
NovoMed Incorporation Pvt. Ltd.
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Self-expanding Vascular Stent System
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Self-expanding Vascular Stent System
Brand: sinus-XL [sinus-XL, sinus-XL 6F]

