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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 SYSTEM
Generic NameProsthesis, intervertebral disc
ApplicantNUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO, CA 92121
PMA NumberP100012
Supplement NumberS005
Date Received12/18/2013
Decision Date03/07/2014
Withdrawal Date 04/22/2020
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO THE PCM INSERTER AND REDEFINING AND TIGHTENING IMPLANT TOLERANCES.
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