Stent Graft System - India CDSCO Medical Device Registration

Stent Graft System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000451_4e1501c99ce27b28129b025c3e7fdcf9_8c512d15b534cc73ecdedce4a8b607f2. This device is marketed under the brand name E-vita Thoracic 3G. The license holder is Vibgyor Health Care 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

Stent Graft System

UID: IMP/MD/2019/000451_4e1501c99ce27b28129b025c3e7fdcf9_8c512d15b534cc73ecdedce4a8b607f2

Brand Name

E-vita Thoracic 3G

License Holder

Vibgyor Health Care Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The E-vita OPEN PLUS Stent Grafts from JOTEC GmbH have been specifically developed for the treatment of aneurysms, dissections and specific lesions of the thoracic aorta. The indications for the use of the E-vita OPEN PLUS Stent Graft from JOTEC GmbH primarily involve acutely life-threatening patient conditions due to: • acute aortic dissections (E-vita Thoracic 3G) extending deep into the descending aorta, • acute aortic dissections (E-vita Thoracic 3G) in combination with Marfan syndrome, • extensive aortic aneurysms of the ascending aorta or ofthe aortic arch extending to the descending aorta (E-vita Thoracic 3G), • complex aortic dissections (E-vita Thoracic 3G) or • chronic extensive aortic dissections

Class D

Brand: E-vita Thoracic 3G

Class D