|
Device | Scoreflex NC Scoring PTCA Catheter |
Generic Name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
Applicant | OrbusNeich Medical (Shenzhen) Co., Ltd. No.1 Jinkui Road, Futian Free Trade Zone Shenzhen 51803 |
PMA Number | P200041 |
Date Received | 09/09/2020 |
Decision Date | 12/21/2021 |
Product Code |
NWX |
Docket Number | 21M-1316 |
Notice Date | 12/22/2021 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT03763747
|
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 |