PMA
P130023: COHERA MEDICAL TISSUGLU
FDA PMA · Tissue adhesive for internal use · Cohera Medical, Inc.
Key facts
| PMA number | P130023 |
|---|---|
| Trade name | COHERA MEDICAL TISSUGLU |
| Generic name | Tissue adhesive for internal use |
| Applicant | Cohera Medical, Inc. |
| Product code | PJK |
| Approval date | Feb 3, 2015 |
| Docket number | 15M-0431 |
| Notice date | Feb 4, 2015 |
| FEI number | 3012970114 |
At a glance
- 1–9 Supplements
- Jul 27, 2017 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: