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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
ApplicantGoodman Co., Ltd.
5f Kdx Nagoya Sakae Bldg., 4-5-3
Sakae, Naka-Ku
Nagoya 
PMA NumberP230026
Supplement NumberS003
Date Received06/22/2026
Decision Date07/22/2026
Product Code NWX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a cleanroom renovation (new equipment) and the relocation of a dust collector machine
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