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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 NumberS001
Date Received06/18/2015
Decision Date07/17/2015
Product Code PJK 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF SPECIFICATIONS TO THE FOIL POUCH MOISTURE BARRIERPACKAGING.
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