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Device | COHERA MEDICAL TISSUGLU |
Generic Name | Tissue adhesive for internal use |
Regulation Number | 878.4010 |
Applicant | COHERA MEDICAL, INC 209 SANDUSKY STREET PITTSBURG, PA 15212 |
PMA Number | P130023 |
Date Received | 11/12/2013 |
Decision Date | 02/03/2015 |
Product Code |
PJK |
Docket Number | 15M-0431 |
Notice Date | 02/04/2015 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT01526954
|
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 S002 S003 S005 |