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CDSCO UID IMP/MD/2021/000692_9822342b079f4c23e558f6bd01e6774a_59a8de92611a6acba2444b63436c4c24

Self-expanding Vascular Stent System

NovoMed Incorporation Pvt. Ltd.·Device Class Class D·India CDSCO·Brand: sinus-XL [sinus-XL, sinus-XL 6F]
Registration details
UID
IMP/MD/2021/000692_9822342b079f4c23e558f6bd01e6774a_59a8de92611a6acba2444b63436c4c24
Device class
Class D
Brand name
sinus-XL [sinus-XL, sinus-XL 6F]
License holder
NovoMed Incorporation Pvt. Ltd.
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.
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About this record

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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