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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 NumberS003
Date Received06/14/2013
Decision Date07/12/2013
Withdrawal Date 03/25/2021
Product Code MJO 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE THE STERILIZATION TESTING PROCEDURE.
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