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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.
 
DeviceScoreflex NC
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantOrbusNeich Medical (Shenzhen) Co., Ltd.
No.1 Jinkui Road, Futian Free Trade Zone
Shenzhen 51803
PMA NumberP200041
Supplement NumberS001
Date Received05/18/2023
Decision Date06/29/2023
Product Code NWX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of a new manufacturing location for the manufacture of select components of the final Scroreflex NC device.
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