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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceCOHERA MEDICAL TISSUGLU
Classification Nametissue adhesive for internal use
Generic Nametissue adhesive for internal use
Regulation Number878.4010
Applicant
COHERA MEDICAL, INC
209 sandusky street
pittsburg, PA 15212
PMA NumberP130023
Date Received11/12/2013
Decision Date02/03/2015
Product Code
PJK[ Registered Establishments with PJK ]
Docket Number 15M-0431
Notice Date 02/04/2015
Advisory Committee General & Plastic Surgery
Clinical Trials NCT01526954
NCT01791504
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 
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