| 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 |
| Supplement Number | S003 |
| Date Received | 03/25/2025 |
| Decision Date | 04/25/2025 |
| Product Code | NWX |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-Day Notice |
| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Expedited Review Granted? | No |
| Combination Product | No |
| Approval Order Statement a change in the welding process for the strength tube and the scoring wire | |
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P200041/S003 review time is faster than 3.9% of similar devices* and 14.8% slower than the median.
* Similar Devices - Devices that share the same advisory committee and supplement type.
| Suppl. # | Suppl. Type & Reason | Approval Order Statement | Received | Decision |
|---|---|---|---|---|
| S001 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Addition of a new manufacturing location for the manufacture of select components of the final scroreflex nc device. |
||
| Original | Original |
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. |
