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CDSCO UID IMP/MD/2020/000136_dff72e7aaa72971a797c0ebea972c3f0_6d140f9864710a5beafb90dd568fd614

Delivery System

India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India·Device Class Class C·India CDSCO·Brand: Ensemble II
Registration details
UID
IMP/MD/2020/000136_dff72e7aaa72971a797c0ebea972c3f0_6d140f9864710a5beafb90dd568fd614
Device class
Class C
Brand name
Ensemble II
License holder
India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India
Approving authority
CDSCO
Product information
The Ensemble DS is designed to allow a physician to deliver a Melody TPV, via venous access, to the area of a failed pulmonary valve previously placed surgically for the repair of congenital heart disease
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About this record

Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000136_dff72e7aaa72971a797c0ebea972c3f0_6d140f9864710a5beafb90dd568fd614. This device is marketed under the brand name Ensemble II. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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