Bifurcation Aneurysm Implant - India CDSCO Medical Device Registration

Bifurcation Aneurysm Implant is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000710_0cc51b2dd288921eb3c3b985f7665b28_32f1724077a0e740df395180735395de. This device is marketed under the brand name pITA. The license holder is Pack Deal, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Bifurcation Aneurysm Implant

UID: IMP/MD/2023/000710_0cc51b2dd288921eb3c3b985f7665b28_32f1724077a0e740df395180735395de

Brand Name

pITA

License Holder

Pack Deal

Device Class

Class D

Approving Authority

CDSCO

Product Information

The pCONUS Bifurcation Aneurysm Implant is a self-expanding, tubular vascular implant for supporting the coil occlusion of wide-neck intracranial bifurcation aneurysms. Indications: The pCONUS Bifurcation Aneurysm Implant is used to support the endovascular coil occlusion of wide-necked bifurcation aneurysms in intracranial arteries. Typical locations for such aneurysms are the bifurcation of the internal carotid artery, the anterior communicating artery, the middle cerebral artery and the bifurcation of the basilar artery. However, in principle, every wide-necked aneurysm in the bifurcation of a vessel can be suitable. Depending on the clinical circumstances and the vascular anatomy, both unruptured and ruptured aneurysms can be treated with this implant. When treating ruptured aneurysms, one must examine carefully to what extent it is possible to use antiplatelet medication