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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePRESTIGE CERVICAL DISC SYSTEM
Classification Nameprosthesis, intervertebral disc
Generic Nameartifical cervical disc
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
PMA NumberP060018
Date Received05/19/2006
Decision Date07/16/2007
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 07M-0289
Notice Date 07/20/2007
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the prestige cervical disc system. This device is indicated for reconstruction of the disc from c3-c7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The prestige device is implanted via an open anterior approach. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e. G. , pain [neck and/or arm pain], functional deficit, and/or neurological deficit), and radiographic studies (e. G. , ct, mri, x-rays, etc. ): 1) herniated disc, and/or 2) osteophyte formation.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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