PMA P200041
- Device
- Scoreflex NC Scoring PTCA Catheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- PMA number
- P200041
- Product code
- NWX
- Decision date
- 2026-07-31
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- approval for a change in supplier for the Nylon 11 tube applied to the ø1.75 – 2.5 mm device configurations from an external supplier to self-production
- Summary
- <a href="https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200041B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Scoreflex NC Scoring PTCA Catheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- PMA number
- P200041
- Supplement
- S005
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2026-07-31
- Decision code
- APPR
- Date received
- 2025-03-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a change in supplier for the Nylon 11 tube applied to the ø1.75 – 2.5 mm device configurations from an external supplier to self-production