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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 NameSCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)
Classification Nameprosthesis, ankle, uncemented, non-constrained
ApplicantSMALL BONE INNOVATIONS, INC.
PMA NumberP050050
Supplement NumberS005
Date Received11/13/2012
Decision Date01/24/2013
Product Code
NTG[ Registered Establishments with NTG ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a revised package insert which includes additional potential adverse events reported in recent star ankle publications.
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