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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.
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis, intervertebral disc
7475 lusk blvd
san diego, CA 92121
PMA NumberP100012
Date Received04/01/2010
Decision Date10/26/2012
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 12M-1111
Notice Date 11/08/2012
Advisory Committee Orthopedic
Clinical Trials NCT00578812
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the pcm cervical disc system. This device is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from c3-c4 to c6-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 disc space, and manifested by at least one of the following conditions confirmed by radiographic 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 pcm cervical disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the pcm cervical disc.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006