- Device
- Lacrosse NSE ALPHA Coronary Dilatation Catheter
- Applicant
- NIPRO VASCULAR CORPORATION (formerly Goodman Co., Ltd.)
- PMA number
- P230026
- Supplement
- S003
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2026-07-22
- Decision code
- OK30
- Date received
- 2026-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a cleanroom renovation (new equipment) and the relocation of a dust collector machine