Paclitaxel Eluting PTCA Balloon Catheter - India CDSCO Medical Device Registration
Paclitaxel Eluting PTCA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000380_8fd25b47986d05eb7960a26acff94c4b_a4c5b213a8ecd87e38e6c8f83d3d48c9. This device is marketed under the brand name 3V SIRIS. The license holder is S3V VASCULAR TECHNOLOGIES LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Bangalore.
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Brand Name
3V SIRIS
License Holder
S3V VASCULAR TECHNOLOGIES LIMITEDDevice Class
Approving Authority
Sub Zonal Bangalore
Product Information
The 3V PAULO PLUS PTCA Catheter is coated with paclitaxel, a highly lipophilic drug, which provides an anti-proliferative treatment in coronary arteries improving myocardial perfusion. The 3V PAULO PLUS is intended for use in the treatment of patients with clinical symptoms of myocardial ischemia related to the pathological condition of one or more coronary arteries and in the management of in-stent restenosis.
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