Approval for a modification to the tissuglu® synthesis process where a small percentage of the stability reagents (sulfuric acid and dmso stock solution) that are normally added at the end of the product synthesis process is instead added at the beginning of synthesis ("borrowed acid process").
| Device | COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE |
| Generic Name | Tissue Adhesive For Internal Use |
| Applicant | COHERA MEDICAL, INC |
| Date Received | 2017-01-26 |
| Decision Date | 2017-07-27 |
| PMA | P130023 |
| Supplement | S005 |
| Product Code | PJK |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 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