COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

FDA Premarket Approval P130023 S003

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.

Pre-market Approval Supplement Details

Relocation of the lab equipment where quality control release testing of the tissuglu surgical adhesive cartridge lots is conducted.

• Device: COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE
• Generic Name: Tissue Adhesive For Internal Use
• Applicant: COHERA MEDICAL, INC
• Date Received: 2016-05-09
• Decision Date: 2017-02-01
• PMA: P130023
• Supplement: S003
• Product Code: PJK
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: COHERA MEDICAL, INC 209 Sandusky Street pittsburg, PA 15212

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