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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 NumberS005
Date Received10/05/2009
Decision Date12/04/2009
Product Code
NEG[ Registered Establishments with NEG ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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