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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(R) LP CERVICAL DISC
Generic Nameprosthesis, intervertebral disc
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 pyramid place
memphis, TN 38132
PMA NumberP090029
Supplement NumberS002
Date Received08/22/2014
Decision Date03/11/2016
Product Code MJO 
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the post-approval study protocol.
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