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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 NumberS006
Date Received04/26/2010
Decision Date08/26/2011
Product Code
NEG[ Registered Establishments with NEG ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the coating supplier manufacturing facility.
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