- Device
- Scoreflex NC
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- PMA number
- P200041
- Supplement
- S001
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2023-06-29
- Decision code
- OK30
- Date received
- 2023-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new manufacturing location for the manufacture of select components of the final Scroreflex NC device.