COHERA MEDICAL TISSUGLU

FDA Premarket Approval P130023

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.

Pre-market Approval Supplement Details

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.

• Device: COHERA MEDICAL TISSUGLU
• Generic Name: Tissue Adhesive For Internal Use
• Applicant: COHERA MEDICAL, INC
• Date Received: 2013-11-12
• Decision Date: 2015-02-03
• Notice Date: 2015-02-04
• PMA: P130023
• Supplement: S
• Product Code: PJK
• Docket Number: 15M-0431
• Advisory Committee: General & Plastic Surgery
• Expedited Review: No
• Combination Product: No
• Applicant Address: COHERA MEDICAL, INC 209 Sandusky Street pittsburg, PA 15212
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P130023		Original Filing
S005	2017-01-26	135 Review Track For 30-day Notice
S004
S003	2016-05-09	30-day Notice
S002	2016-02-02	Normal 180 Day Track No User Fee
S001	2015-06-18	Special (immediate Track)

NIH GUDID Devices

Device ID	PMA	Supp
M690TG100US0	P130023	000