Coronary Orbital Atherectomy System - India CDSCO Medical Device Registration
Coronary Orbital Atherectomy System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000668_dfdcf0329f9cf6a4ad929bf761fc0254_4654a45c08663b8951da9346080def29. This device is marketed under the brand name Diamondback 360. The license holder is Innvolution Healthcare Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Diamondback 360
License Holder
Innvolution Healthcare Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
The Diamondback 360° Coronary Orbital Atherectomy System (Diamondback 360) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (Diamondback 360) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions
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