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/2023/000710_28de5a679afc2238f0e6b62ca1bb7a34_7c04c2cd1c34030c75ef33bca674fb4c. 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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Brand Name
pITA
License Holder
Pack DealDevice Class
Approving Authority
CDSCO
Product Information
The p48 MW (pITA) 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 p48 MW (pITA) straighten the target vessel slightly and reinforce it. These properties aid the endovascular reconstruction of diseased arteries along their cervical and intracranial course. Indications: The p48 MW (pITA) 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 and ▪ vascular perforations and AV fistulae.
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