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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.
 
DeviceactiveL Artificial Disc
Generic Nameprosthesis, intervertebral disc
ApplicantAESCULAP IMPLANT SYSTEMS, LLC
3773 corporate parkway
center valley, PA 18034
PMA NumberP120024
Supplement NumberS008
Date Received03/29/2019
Decision Date05/13/2019
Product Code MJO 
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for MR Conditional labeling for the activeL keel endplates.
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