Lacrosse NSE ALPHA Coronary Dilatation Catheter
FDA premarket approval P230026/S003 · decided 2026-07-22
Approval details
- PMA number
- P230026
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lacrosse NSE ALPHA Coronary Dilatation Catheter
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Applicant
- Goodman Co., Ltd.
- Date received
- 2026-06-22
- Decision date
- 2026-07-22
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NWX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nagoya
- Statement
- a cleanroom renovation (new equipment) and the relocation of a dust collector machine
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