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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 NumberS003
Date Received11/08/2002
Decision Date07/02/2003
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
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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