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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.
 
DeviceBarricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb
Generic NameReherniation reduction device
ApplicantIntrinsic Therapeutics
30 Commerce Way
Woburn, MA 01801
PMA NumberP160050
Supplement NumberS009
Date Received06/05/2024
Decision Date07/03/2024
Product Code QES 
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  
a site change for the approved supplier that manufactures and assembles sub-components to the pusher instrument and an addition of a secondary supplier to the final passivation step of the bone anchor component of the final implant device
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