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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 STREAMLINED INSTRUMENTS
Generic NameProsthesis, intervertebral disc
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP090029
Supplement NumberS007
Date Received12/22/2016
Decision Date04/03/2017
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Prestige LP Cervical Disc streamlined instrument set, which primarily includes updates to the implant trial, drill guide, and rail punch instruments.
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