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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
Classification Nameprosthesis, ankle, uncemented, non-constrained
ApplicantSMALL BONE INNOVATIONS, INC.
PMA NumberP050050
Supplement NumberS001
Date Received08/05/2009
Decision Date10/08/2010
Product Code
NTG[ Registered Establishments with NTG ]
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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