PMA
P130004: RESURE SEALANT
FDA PMA · Ophthalmic Sealant · Ocular Therapeutix, Inc.
Key facts
| PMA number | P130004 |
|---|---|
| Trade name | RESURE SEALANT |
| Generic name | Ophthalmic Sealant |
| Applicant | Ocular Therapeutix, Inc. |
| Product code | PFZ |
| Approval date | Jan 8, 2014 |
| Docket number | 14M-0069 |
| Notice date | Jan 15, 2014 |
| FEI number | 3008477155 |
At a glance
- 10–99 Supplements
- Nov 2, 2021 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- No Withdrawn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: