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
| Device | Scoreflex NC Scoring PTCA Catheter |
| Generic Name | Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring |
| Applicant | OrbusNeich Medical (Shenzhen) Co., Ltd. |
| Date Received | 2020-09-09 |
| Decision Date | 2021-12-21 |
| PMA | P200041 |
| Supplement | S |
| Product Code | NWX |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| 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
| Supplement Number | Date | Supplement Type |
|---|
| P200041 | | Original Filing |
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NIH GUDID Devices