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Atrial Septal Defect Occluder - India CDSCO Medical Device Registration

Atrial Septal Defect Occluder is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000404_4fecf416a6d797b1c78d134211b57521_4b4c00935417e2a4d9502bb5b9942b5c. This device is marketed under the brand name ASD. The license holder is Lifetech Scientific India Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Atrial Septal Defect Occluder
UID: IMP/MD/2018/000404_4fecf416a6d797b1c78d134211b57521_4b4c00935417e2a4d9502bb5b9942b5c

Brand Name

ASD

Device Class

Class D

Approving Authority

CDSCO

Product Information

The CeraTM ASD Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defect (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for ASD closure have echocardiograghic evidence of (ASD) ostium secundem atrial septal defect and clinical evidence of right ventricular volume overload

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