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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.
 
DevicePrestiege LP Cervical Disc - Two-Level
Generic NameProsthesis, intervertebral disc
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP090029
Supplement NumberS013
Date Received09/26/2019
Decision Date03/06/2020
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for labeling for the Prestige LP Cervical Disc which incorporated the final results of the 10-year Extended Follow-Up of IDE Subjects Post-Approval Study.
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