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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM STAR ANKLE
Classification Nameprosthesis, ankle, uncemented, non-constrained
Generic Nameprosthesis, ankle, uncemented, non-constrained
Applicant
STRYKER CORPORATION
bohnackerweg 1
selzach CH 25
PMA NumberP050050
Supplement NumberS006
Date Received03/10/2014
Decision Date06/04/2014
Product Code
NTG[ Registered Establishments with NTG ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGING THE INNER POUCH MATERIAL FOR THE STAR SLIDING CORE COMPONENT.
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