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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 NameAFFINITY ANTERIOR CERVICAL CAGE SYSTEM
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral cervical device
Regulation Number888.3080
Applicant MEDTRONIC INC.
PMA NumberP000028
Supplement NumberS008
Date Received04/20/2006
Decision Date07/25/2006
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the device labeling to incorporate data collected from the post market study of the device.
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