Lacrosse NSE ALPHA Coronary Dilatation Catheter
FDA premarket approval P230026/S001 · decided 2024-08-02
Approval details
- PMA number
- P230026
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Lacrosse NSE ALPHA Coronary Dilatation Catheter
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Applicant
- Goodman Co., Ltd.
- Date received
- 2024-07-03
- Decision date
- 2024-08-02
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NWX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nagoya
- Statement
- P230026 PAS protocol is approved.
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