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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 NumberS004
Date Received12/13/2012
Decision Date01/11/2013
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  
USE OF A NEW LOCATION FOR THE POROUS COATING PROCESS PERFORMED AT THE FIRM¿S SUPPLIER.
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