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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.
 
DeviceTOTAL TRAPEZIO METACARPAL PROSTHESIS
Generic NameProsthesis, finger, constrained, metal/polymer
Regulation Number888.3220
ApplicantStryker Corporation
Bohnackerweg 1
Selzach CH 2545
PMA NumberP960053
Supplement NumberS001
Date Received03/31/1998
Decision Date06/04/1998
Product Code KWG 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR 1) PACKAGING THE IMPLANT IN A SINGLE BOX CONTAINING BOTH THE PROXIMAL AND DISTAL COMPONENTS AND CHANGING PACKAGE LABELS ACCORDINGLY, AND 2) CHANGING THE COLOR OF STOCK USED FOR PRINTING BOX LABELS.
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