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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.
 
DeviceBRYAN Cervical Disc
Generic NameProsthesis, intervertebral disc
ApplicantCompanion Spine France Sas
Immeuble Le Bridge 3
5 Allee Des Acacias
Merignac 33 700
PMA NumberP060023
Supplement NumberS008
Date Received10/18/2019
Decision Date03/18/2020
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling for the BRYAN® Cervical Disc which incorporate the final results of the 10-year Post-Approval Study and Enhanced Surveillance findings.
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