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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NamePRESTIGE LP CERVICAL DISC
Classification Nameprosthesis, intervertebral disc
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP090029
Date Received12/22/2009
Decision Date07/24/2014
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 14M-1113
Notice Date 08/07/2014
Advisory Committee Orthopedic
Clinical Trials NCT00637156
NCT00667459
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the prestige® lp cervical disc. This device is indicated in skeletally mature patients for reconstruction of the disc at one level from c3-c7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level 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
Post-Approval StudyShow Report Schedule and Study Progress
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