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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 ARTIFICIAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantAESCULAP IMPLANT SYSTEMS, LLC
3773 Corporate Parkway
Center Valley, PA 18034
PMA NumberP120024
Supplement NumberS002
Date Received08/07/2015
Decision Date11/04/2015
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 CHANGES TO THE ACTIVL® ARTIFICIAL DISC LABELING THAT PROPOSED CHANGES TO THE INSTRUCTIONS FOR USE, SURGICAL TECHNIQUE, PATIENT BROCHURE, AND PACKAGE LABEL TO REFLECT THE MR TESTING THAT WAS CONDUCTED.
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