PMA
P110007: HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
FDA PMA · AID, SURGICAL, VISCOELASTIC · Johnson & Johnson Surgical Vision, Inc.
Key facts
| PMA number | P110007 |
|---|---|
| Trade name | HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE) |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Owner/operator | Johnson & Johnson Surgical Vision, Inc. |
| Product code | LZP |
| Approval date | Jul 2, 2012 |
| Docket number | 12M-0734 |
| Notice date | Jul 16, 2012 |
| Establishment registration | 3012236936 |
| FEI number | 3012236936 |
At a glance
- 10–99 Supplements
- Jan 15, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: