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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 NumberS003
Date Received05/09/2016
Decision Date02/01/2017
Product Code PJK 
Advisory Committee General & Plastic Surgery
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  
Relocation of the lab equipment where quality control release testing of the TissuGlu Surgical Adhesive cartridge lots is conducted.
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