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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNUVASIVE PCM CERVICAL DISC SYSTEM
Generic NameProsthesis, intervertebral disc
ApplicantNUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO, CA 92121
PMA NumberP100012
Date Received04/01/2010
Decision Date10/26/2012
Withdrawal Date 04/22/2020
Product Code MJO 
Docket Number 12M-1111
Notice Date 11/08/2012
Advisory Committee Orthopedic
Clinical TrialsNCT00578812
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S008 
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