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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLacrosse NSE ALPHA Coronary Dilatation Catheter
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantNIPRO VASCULAR CORPORATION (formerly Goodman Co., Ltd.)
5f Kdx Nagoya Sakae Bldg., 4-5-3
Sakae, Naka-Ku
Nagoya 
PMA NumberP230026
Supplement NumberS001
Date Received07/03/2024
Decision Date08/02/2024
Product Code NWX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
P230026 PAS protocol is approved.
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