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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 MCP
Classification Namefinger semi-constrained pyrolytic carbon uncemented prosthesis
Generic Nameprosthesis, finger joint (metacarpophalangeal)
ApplicantASCENSION ORTHOPEDICS, INC.
PMA NumberP000057
Supplement NumberS003
Date Received02/06/2006
Decision Date07/17/2006
Product Code
NEG[ Registered Establishments with NEG ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add a size 05 implant to the product line.
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