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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 ORTHOPEDICS MCP
Generic NameFinger semi-constrained pyrolytic carbon uncemented prosthesis
ApplicantSmith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova, TN 38016
PMA NumberP000057
Supplement NumberS004
Date Received02/19/2008
Decision Date04/24/2008
Product Code NEG 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD A HYDROXYAPATITE (HA) COATING TO TE STEM OF THE ASCENSION MCP PROXIMAL AND DISTAL COMPONENTS.
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