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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.
 
DeviceCOHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE
Generic NameTissue adhesive for internal use
Regulation Number878.4010
ApplicantCohera Medical, Inc.
209 Sandusky St.
Pittsburgh, PA 15212
PMA NumberP130023
Supplement NumberS002
Date Received02/02/2016
Decision Date06/23/2017
Product Code PJK 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Ximedica LLC, 55 Dupont Drive, Providence, Rhode Island, as a facility for cartridge filling, device assembly, packaging, management of sterilization, and final product release.
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