Self-expanding Vascular Stent System
- UID
- IMP/MD/2021/000692_9822342b079f4c23e558f6bd01e6774a_20aa186f200a6c365e59b7820723f4d9
- Device class
- Class D
- Brand name
- sinus-XL [sinus-XL, sinus-XL 6F]
- License holder
- NovoMed Incorporation Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Sinus-XL [In the Aorta abdominalis and straight section of the Aorta thorakalis descendens: • Insufficient outcome of angioplasty treatment • Residual stenosis following balloon angioplasty • Dissection • Elastic stenosis of bypass anastomoses • Vascular obliteration / Stenosis • Endoleak type 1a and 1b In straight sections of the vena cava: • Superior and inferior vena cava syndrome • 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: • Vascular occlusions / Stenosis • Dissection • Insufficient outcome of angioplasty treatment • 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 The safety and performance of the sinus-XL 6F cannot be guaranteed under indications other than the above.]
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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