PMA P230026S001
- Device
- Lacrosse NSE ALPHA Coronary Dilatation Catheter
- Applicant
- NIPRO VASCULAR CORPORATION (formerly Goodman Co., Ltd.)
- PMA number
- P230026
- Supplement
- S001
- Product code
- NWX
- Decision date
- 2024-08-02
- Classification
- Cardiovascular
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- P230026 PAS protocol is approved.
Current openFDA PMA Record#
- Device
- Lacrosse NSE ALPHA Coronary Dilatation Catheter
- Applicant
- NIPRO VASCULAR CORPORATION (formerly Goodman Co., Ltd.)
- PMA number
- P230026
- Supplement
- S001
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2024-08-02
- Decision code
- APPR
- Date received
- 2024-07-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- P230026 PAS protocol is approved.