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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 Anular Closure Device (ACD)
Generic NameReherniation reduction device
ApplicantINTRINSIC THERAPEUTICS
30 COMMERCE WAY
WOBURN, MA 01801
PMA NumberP160050
Supplement NumberS003
Date Received03/19/2019
Decision Date03/17/2020
Product Code QES 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to change the supplier and specifications of the polyester yarn used to make the mesh of the woven fabric for the flexible occlusion component of the Barricaid Anular Closure Device (ACD).
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