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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 TISSUGLU SURGICAL ADHESIVE
Generic NameTissue adhesive for internal use
Regulation Number878.4010
ApplicantCohera Medical, Inc.
209 Sandusky St.
Pittsburgh, PA 15212
PMA NumberP130023
Supplement NumberS005
Date Received01/26/2017
Decision Date07/27/2017
Product Code PJK 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modification to the TissuGlu® synthesis process where a small percentage of the stability reagents (sulfuric acid and DMSO stock solution) that are normally added at the end of the product synthesis process is instead added at the beginning of synthesis ("borrowed acid process").
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