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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
Generic NameReherniation reduction device
ApplicantIntrinsic Therapeutics
30 Commerce Way
Woburn, MA 01801
PMA NumberP160050
Supplement NumberS008
Date Received01/10/2024
Decision Date02/08/2024
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 change to the material supplier for the nonabsorbable surgical suture sub-component used to assemble the polymer mesh component of the final device
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