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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameASCENSION ORTHOPEDICS MCP
Classification Namefinger semi-constrained pyrolytic carbon uncemented prosthesis
Generic Nameprosthesis, finger joint (metacarpophalangeal)
ApplicantASCENSION ORTHOPEDICS, INC.
PMA NumberP000057
Supplement NumberS004
Date Received02/26/2008
Decision Date04/24/2008
Product Code
NEG[ Registered Establishments with NEG ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
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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