PMA P200041S002
- Device
- Scoreflex NC Scoring PTCA Catheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- PMA number
- P200041
- Supplement
- S002
- Product code
- NWX
- Decision date
- 2024-08-01
- Classification
- Cardiovascular
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- alternate suppliers for the middle tip, hypotube, and marker bands
Current openFDA PMA Record#
- Device
- Scoreflex NC Scoring PTCA Catheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- PMA number
- P200041
- Supplement
- S002
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2024-08-01
- Decision code
- OK30
- Date received
- 2024-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- alternate suppliers for the middle tip, hypotube, and marker bands