PMA supplement
P200041 S007: Scoreflex NC Scoring PTCA Catheter
FDA PMA supplement · 30-Day Notice · OrbusNeich Medical (Shenzhen) Co., Ltd.
Key facts
| Original PMA | P200041 |
|---|---|
| Supplement number | S007 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Scoreflex NC Scoring PTCA Catheter |
| Generic name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
| Applicant | OrbusNeich Medical (Shenzhen) Co., Ltd. |
| Product code | NWX |
| Received date | Apr 29, 2025 |
| Decision date | May 29, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: