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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.
 
DeviceASCENSION MCP
Generic NameFinger semi-constrained pyrolytic carbon uncemented prosthesis
ApplicantSmith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova, TN 38016
PMA NumberP000057
Supplement NumberS014
Date Received07/09/2025
Decision Date08/05/2025
Product Code NEG 
Advisory Committee Orthopedic
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  
Approval to introduce new quarterly product endotoxin testing.
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