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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 LP Cervical Disc
Generic NameProsthesis, intervertebral disc
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP090029
Supplement NumberS018
Date Received08/25/2023
Decision Date02/21/2024
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to update labeling for the Prestige LP Cervical Disc to reflect the findings of the 2-Level Metal Concentration Study (PAS2).
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