PMA
P200041: Scoreflex NC Scoring PTCA Catheter
FDA PMA · Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring · OrbusNeich Medical (Shenzhen) Co., Ltd.
Key facts
| PMA number | P200041 |
|---|---|
| Trade name | Scoreflex NC Scoring PTCA Catheter |
| Generic name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
| Applicant | OrbusNeich Medical (Shenzhen) Co., Ltd. |
| Owner/operator | ORBUSNEICH MEDICAL CO. LTD (HONG KONG) |
| Product code | NWX |
| Approval date | Dec 21, 2021 |
| Docket number | 21M-1316 |
| Notice date | Dec 22, 2021 |
| Establishment registration | 3003775186 |
| FEI number | 3003775186 |
At a glance
- 10–99 Supplements
- Jul 31, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: