PTCA Balloon Catheter - India CDSCO Medical Device Registration
PTCA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000366_35f2171fa613585bd5d0311eff170695_44bb409cecfb720cfbf9b4eedc4bf055. This device is marketed under the brand name Foxtrot NC PTCA Balloon Catheter. The license holder is MicroPort Scientific India Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Foxtrot NC PTCA Balloon Catheter
License Holder
MicroPort Scientific India Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
FOXTROT PRO is indicated for balloon pre-dilatation of the stenotic atherosclerotic lesions in patients with following coronary artery diseases: Angina pectoris (Foxtrot NC PTCA Balloon Catheter); Myocardial infarction (Foxtrot NC PTCA Balloon Catheter); One or more stenosis in one vessel; Multi-vessel stenosis and distal vessel stenosis; Coronary artery re-stenosis after coronary artery bypass graft (Foxtrot NC PTCA Balloon Catheter); Coronary artery re-stenosis after PTCA; Protected left main coronary artery stenosis
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