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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 NamePRESTIGE CERVICAL DISC
Classification Nameprosthesis, intervertebral disc
Generic Nameartifical cervical disc
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
PMA NumberP060018
Supplement NumberS001
Date Received09/07/2007
Decision Date09/18/2007
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the surgical technique manual (i. E. , modification of figure 8 and the addition of a cautionary note).
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