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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 NumberS012
Date Received07/09/2020
Decision Date08/05/2020
Product Code NQO 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for additional warnings in the labeling.
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