| 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. |
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| Trade Name | NUVASIVE PCM CERVICAL DISC SYSTEM |
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| Classification Name | prosthesis, intervertebral disc |
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| Applicant | NUVASIVE, INC. |
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| PMA Number | P100012 |
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| Date Received | 04/01/2010 |
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| Decision Date | 10/26/2012 |
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| Product Code | |
| Docket Number | 12M-1111 |
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| Notice Date | 11/08/2012 |
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| Advisory Committee |
Orthopedic |
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| Clinical Trials |
NCT00578812
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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
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| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 S002 S003 S004 |
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