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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.
 
DeviceNU VASIVE PCM CERVICAL DISC SYSTEM
Generic NameProsthesis, intervertebral disc
ApplicantNuvasive, Inc.
7475 Lusk Blvd.
San Diego, CA 92121
PMA NumberP100012
Supplement NumberS006
Date Received09/26/2014
Decision Date12/19/2014
Withdrawal Date04/22/2020
Product Code MJO 
Advisory Committee Orthopedic
Clinical TrialsNCT00578812
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A LOCKING PLATE DESIGN MODIFICATION, ADDITIONAL DEVICE SIZES AND MAGNETIC RESONANCE (MR) CONDITIONAL LABELING.
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