CDSCO UID IMP/MD/2022/000188_e3072ffee1f6efc4bb60602fe90d1010_c4aaabd8de4aa97c89c00a0e66f0c968

Peripheral Stent

Cardinal Health Medical Products India Pvt Ltd·Device Class Class C·India CDSCO·Brand: PALMAZ™
Registration details
UID
IMP/MD/2022/000188_e3072ffee1f6efc4bb60602fe90d1010_c4aaabd8de4aa97c89c00a0e66f0c968
Device class
Class C
Brand name
PALMAZ™
Approving authority
CDSCO
Product information
The PALMAZ balloon-expandable Stent is indicated for use in peripheral vessels below the aortic arch in patients who are acceptable candidates for percutaneous transluminal angioplasty. The lumen diameter of all vessels between the entry site and the lesion site must be large enough to accept a 12F or 13F introducer sheath. If the vessels are not large enough due to a lesion, an angioplasty procedure must be performed to produce a lumen of sufficient size. The target vessel must be large enough to accommodate the stent expanded to 15mm. In order to perform a successful stent implantation, a CT scan is recommended to ensure the accurate measurement of the passage vessels and the target vessel.
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About this record

Peripheral Stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000188_e3072ffee1f6efc4bb60602fe90d1010_c4aaabd8de4aa97c89c00a0e66f0c968. This device is marketed under the brand name PALMAZ™. The license holder is Cardinal Health Medical Products India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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