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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(TM) 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 NumberS003
Date Received06/03/2015
Decision Date07/07/2016
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 16M-2182
Notice Date 07/25/2016
Advisory Committee Orthopedic
Clinical Trials NCT00637156
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Prestige LP Cervical Disc. This device is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The PRESTIGE LP™ Cervical Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of non-operative treatment or have had the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management prior to implantation of the PRESTIGE LP Cervical Disc.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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