Flow Modulation Device - India CDSCO Medical Device Registration
Flow Modulation Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000537_28de5a679afc2238f0e6b62ca1bb7a34_628f1a4e77cd43d8adeacf16036feccb. 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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Brand Name
pFMD
License Holder
Sunrise Imaging SystemsDevice Class
Approving Authority
CDSCO
Product Information
The p64 Flow Modulation Device is a self-expanding, tubular vascular implant and allows the controlled and selective modulation of blood flow in extra- and intracranial arteries. In addition, the physical properties of the p64 straighten the target vessel slightly and strengthen it. These properties aid the endovascular reconstruction of diseased arteries along their cervical and intracranial course. INDICATIONS: The p64 Flow Modulation Device is a self-expanding, tubular implant and is used in the endovascular treatment of vascular diseases such as - saccular and fusiform aneurysms and pseudoaneurysms - vascular dissections in the acute and chronic phases - vascular perforations and AV fistulae
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