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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 and prodisc - C Nova (Indicated for Single Level Use)
Generic NameProsthesis, intervertebral disc
ApplicantCentinel Spine, LLC
900 Airport Rd., Suite 3b
West Chester, PA 19380
PMA NumberP070001
Supplement NumberS026
Date Received02/06/2024
Decision Date03/01/2024
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modification to the device labeling to include the addition of the following precaution statement: “Precaution: The safety and effectiveness of the prodisc C, when implanted at more than one cervical spinal level and/or adjacent to an anterior cervical discectomy and fusion (ACDF) has not been established.”
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