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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceScoreflex NC Scoring PTCA Catheter
Generic Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantOrbusNeich Medical (Shenzhen) Co., Ltd.
no.1 jinkui road, futian free trade zone
shenzhen 51803
PMA NumberP200041
Date Received09/09/2020
Decision Date12/21/2021
Product Code NWX 
Docket Number 21M-1316
Notice Date 12/22/2021
Advisory Committee Cardiovascular
Clinical TrialsNCT03763747
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Scoreflex NC Scoring PTCA Catheter. The device is indicated for: Balloon dilatation of a de novo stenotic portion of a coronary artery and in-stent restenosis in coronary arteries in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness