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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
Generic NameProsthesis, intervertebral disc
ApplicantCentinel Spine, LLC
900 Airport Rd., Suite 3b
West Chester, PA 19380
PMA NumberP070001
Supplement NumberS021
Date Received09/21/2021
Decision Date10/28/2021
Product Code MJO 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Expand the responsibilities of Hammill Medical (360 Tomahawk Drive Maumee, OH 43537) to perform the following for the prodisc -C modified endplates (-SK, -NOVO, and -VIVO) once the modified endplates are approved: acquire the raw material, machine the endplate components, polish the superior endplates, complete inspections and bead blast the endplates.
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