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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'S PCM CERVICAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantNuvasive, Inc.
7475 Lusk Blvd.
San Diego, CA 92121
PMA NumberP100012
Supplement NumberS003
Date Received11/19/2012
Decision Date04/10/2013
Withdrawal Date04/22/2020
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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