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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 NumberS013
Date Received09/27/2024
Decision Date12/31/2025
Product Code NEG 
Advisory Committee Orthopedic
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 to the raw material used in the processing of the subject device
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