Scoreflex NC Scoring PTCA Catheter

FDA Premarket Approval P200041

Pre-market Approval Supplement Details

The scoreflex nc scoring ptca catheter 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

DeviceScoreflex NC Scoring PTCA Catheter
Generic NameCatheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
ApplicantOrbusNeich Medical (Shenzhen) Co., Ltd.
Date Received2020-09-09
Decision Date2021-12-21
PMAP200041
SupplementS
Product CodeNWX 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address OrbusNeich Medical (Shenzhen) Co., Ltd. no.1 Jinkui Road, Futian Free Trade Zone shenzhen 51803
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order:Approval Order

Supplemental Filings

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Supplement NumberDateSupplement Type
P200041Original Filing

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