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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
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
Supplements:  S001