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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.
 
DevicePRESTIGE CERVICAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP060018
Supplement NumberS001
Date Received09/07/2007
Decision Date09/18/2007
Withdrawal Date 03/25/2021
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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