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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
Recalls CDRH Recalls
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 S003 
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