CDSCO UID IMP/MD/2019/000537_0cc51b2dd288921eb3c3b985f7665b28_54bff897f7d5da7c919249848cc4227d

Bifurcation Aneurysm Implant

Sunrise Imaging Systems·Device Class Class D·India CDSCO·Brand: pFMD
Registration details
UID
IMP/MD/2019/000537_0cc51b2dd288921eb3c3b985f7665b28_54bff897f7d5da7c919249848cc4227d
Device class
Class D
Brand name
pFMD
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
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About this record

Bifurcation Aneurysm Implant is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000537_0cc51b2dd288921eb3c3b985f7665b28_54bff897f7d5da7c919249848cc4227d. This device is marketed under the brand name pFMD. The license holder is Sunrise Imaging Systems, and it is classified as Device Class Class D. The approving authority is CDSCO.

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