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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 Scoring PTCA Catheter
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantOrbusNeich Medical (Shenzhen) Co., Ltd.
#1 Jinkui Rd.
Futian Free Trade Zone
Shenzhen 518038
PMA NumberP200041
Supplement NumberS005
Date Received03/31/2025
Decision Date07/31/2026
Product Code NWX 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a change in supplier for the Nylon 11 tube applied to the ø1.75 – 2.5 mm device configurations from an external supplier to self-production
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