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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 NumberS003
Date Received11/08/2002
Decision Date07/02/2003
Reclassified Date 07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITIONAL MANUFACTURING FACILITY TO PERFORM PACKAGING FOR TERMINAL STERILIZATION. THE FACILITY IS LOCATED AT MEDTRONIC SOFAMOR DANEK, WARSAW, INDIANA. ALSO, APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA STERIGENICS, WESTERVILLE, OHIO AND AN ADDITIONAL TESTING FACILITY LOCATED AD NAMSA, NORTHWOOD, OHIO.
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