Lacrosse NSE ALPHA Coronary Dilatation Catheter
FDA premarket approval P230026 · decided 2024-06-06
Approval details
- PMA number
- P230026
- Trade name
- Lacrosse NSE ALPHA Coronary Dilatation Catheter
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Applicant
- Goodman Co., Ltd.
- Date received
- 2023-08-31
- Decision date
- 2024-06-06
- Days to decision
- 280 days
- Decision code
- APPR
- Product code
- NWX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nagoya
- Statement
- The Lacrosse NSE ALPHA Coronary Dilatation Catheter is device is indicated for balloon dilatation of the stenotic portion of the coronary artery including both de novo and in-stent restenosis, for the purpose of improving myocardial perfusion.
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