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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCOHERA MEDICAL TISSUGLU
Generic NameTissue adhesive for internal use
Regulation Number878.4010
ApplicantCohera Medical, Inc.
209 Sandusky St.
Pittsburgh, PA 15212
PMA NumberP130023
Date Received11/12/2013
Decision Date02/03/2015
Product Code PJK 
Docket Number 15M-0431
Notice Date 02/04/2015
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01526954
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE TISSUGLU® SURGICAL ADHESIVE. THIS DEVICE IS INDICATED FOR THE APPROXIMATION OF TISSUE LAYERS WHERE SUBCUTANEOUS DEAD SPACE EXISTS BETWEEN THE TISSUE PLANES IN ABDOMINOPLASTY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S005 
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