CDSCO UID MFG/MD/2019/000174_be419e255485cc8d04487a33d17e2365_12608dcb52c9a11e254146c37c9f328a
PTCA Balloon Catheter (ADVA GLIDE , CLEVER )
Advanced MedTech Solutions Private Limited·Device Class Class D·India CDSCO·Brand: SUPERGUT
Registration details
- UID
- MFG/MD/2019/000174_be419e255485cc8d04487a33d17e2365_12608dcb52c9a11e254146c37c9f328a
- Device class
- Class D
- Brand name
- SUPERGUT
- License holder
- Advanced MedTech Solutions Private Limited
- 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
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About this record
PTCA Balloon Catheter (ADVA GLIDE , CLEVER ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000174_be419e255485cc8d04487a33d17e2365_12608dcb52c9a11e254146c37c9f328a. 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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