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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.
 
DeviceAFFINITY ANTERIOR CERVICAL CAGE SYSTEM
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000028
Supplement NumberS004
Date Received08/27/2003
Decision Date11/13/2003
Reclassified Date 07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A REVISED EXPLANT PROTOCOL.
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