PTCA Balloon Catheter (ADVA ONE , CONIC ONE ) - India CDSCO Medical Device Registration

PTCA Balloon Catheter (ADVA ONE , CONIC ONE ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000174_c78810d39bacd816bf29fc28811f2646_39cd3301cc9c750265d4ecf42f200725. This device is marketed under the brand name SUPERGUT. The license holder is Advanced MedTech Solutions Private Limited, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

PTCA Balloon Catheter (ADVA ONE , CONIC ONE )

UID: MFG/MD/2019/000174_c78810d39bacd816bf29fc28811f2646_39cd3301cc9c750265d4ecf42f200725

Brand Name

SUPERGUT

License Holder

Advanced MedTech Solutions Private Limited

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The clinical data presently available indicates that the luminal diameter of a coronary artery at the site of certain types of stenotic lesions can be increased by balloon dilatation and that PTCA is a safe and efficacious procedure for reduction of some forms of atherosclerotic coronary artery disease (SUPERGUT). INDICATIONS: Percutaneous transluminal coronary angioplasty (SUPERGUT) can be indicated by the physician in patients with significant coronary artery disease who are acceptable candidates for coronary artery bypass graft surgery and who meet one of the following selection criteria: 1. Atherosclerotic coronary artery disease that is accessible with a dilatation catheter. 2. Coronary artery disease of the native coronary arteries and/or coronary artery bypass grafts of some patients who have previously undergone coronary artery bypass graft surgery and who have recurrence of symptoms and (SUPERGUT) progression of disease or (SUPERGUT) stenosis and closure of the grafts