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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 NumberS005
Date Received04/16/2020
Decision Date05/12/2020
Product Code QES 
Advisory Committee Orthopedic
Clinical TrialsNCT01283438
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.
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