Approval for a manufacturing site located at ximedica llc, 55 dupont drive, providence, rhode island, as a facility for cartridge filling, device assembly, packaging, management of sterilization, and final product release.
| Device | COHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE |
| Generic Name | Tissue Adhesive For Internal Use |
| Applicant | COHERA MEDICAL, INC |
| Date Received | 2016-02-02 |
| Decision Date | 2017-06-23 |
| PMA | P130023 |
| Supplement | S002 |
| Product Code | PJK |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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