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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.
 
DeviceactivL Artifical Disc
Generic NameProsthesis, intervertebral disc
ApplicantAESCULAP IMPLANT SYSTEMS, LLC
3773 Corporate Parkway
Center Valley, PA 18034
PMA NumberP120024
Supplement NumberS009
Date Received09/09/2019
Decision Date08/12/2020
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for modifications to the labeling resulting from Post Approval Study (PAS) follow-up protocol.
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