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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.
 
Deviceprodisc® C Nova
Generic NameProsthesis, intervertebral disc
ApplicantCentinel Spine, LLC
900 Airport Rd., Suite 3b
West Chester, PA 19380
PMA NumberP070001
Supplement NumberS031
Date Received05/12/2026
Decision Date09/09/2026
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for the prodisc® C Nova requesting expansion of the indications from one-level use to two-level use.
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