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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.
 
Devicecoflex® Interlaminar Technology
Generic NameProsthesis, spinous process spacer/plate
ApplicantCompanion Spine France
Immeuble Le Bridge - 5 Allee Des Acacias
Merignac Gironde 33700
PMA NumberP110008
Supplement NumberS006
Date Received09/01/2016
Decision Date11/30/2016
Product Code NQO 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to the coflex® labeling to indicate a 5-year shelf-life for coflex® devices manufactured by the second source manufacturer, Orchid.
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