PTCA Balloon Catheter
- UID
- IMP/MD/2020/000488_35f2171fa613585bd5d0311eff170695_f3b3dd0ff9b58e9220413b2528be591b
- Device class
- Class D
- Brand name
- FirehawkTM Rapamycin Target Eluting Coronary Stent
- License holder
- Purple MicroPort Cardiovascular Private Limited
- Approving authority
- CDSCO
- Product information
- FOXTROTTM PRO is indicated for balloon pre-dilatation of the stenotic atherosclerotic lesions in patients with following coronary artery diseases: • Angina pectoris (FirehawkTM Rapamycin Target Eluting Coronary Stent) • Myocardial infarction (FirehawkTM Rapamycin Target Eluting Coronary Stent) • One or more stenosis in one vessel; • Multi-vessel stenosis and distal vessel stenosis • Coronary artery restenosis after coronary artery bypass graft (FirehawkTM Rapamycin Target Eluting Coronary Stent) • Coronary artery re-stenosis after PTCA • Protected left main coronary artery stenosis
PTCA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000488_35f2171fa613585bd5d0311eff170695_f3b3dd0ff9b58e9220413b2528be591b. This device is marketed under the brand name FirehawkTM Rapamycin Target Eluting Coronary Stent. The license holder is Purple MicroPort Cardiovascular Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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