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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNuVasive PCM Cervical Disc
Generic NameProsthesis, intervertebral disc
ApplicantNuvasive, Inc.
7475 Lusk Blvd.
San Diego, CA 92121
PMA NumberP100012
Supplement NumberS008
Date Received05/03/2018
Decision Date04/03/2019
Withdrawal Date04/22/2020
Product Code MJO 
Advisory Committee Orthopedic
Clinical TrialsNCT01905930
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling updated to include post-approval study results.
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