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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 NumberS014
Date Received03/18/2020
Decision Date04/15/2020
Product Code MJO 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change in the manufacturing process for machining of the Upper and Lower system components; and (2) a change to the packaging process for packaging the as sterilized Prestige LP Cervical Disc implants.
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