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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
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis, intervertebral disc
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 pyramid place
memphis, TN 38132
PMA NumberP090029
Supplement NumberS006
Date Received08/05/2016
Decision Date12/15/2016
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the protocol for the post-approval study (PAS) protocol.
Post-Approval StudyShow Report Schedule and Study Progress
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