PMA
P810031: HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
FDA PMA · AID, SURGICAL, VISCOELASTIC · Johnson & Johnson Surgical Vision, Inc.
Key facts
| PMA number | P810031 |
|---|---|
| Trade name | HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Owner/operator | Johnson & Johnson Surgical Vision, Inc. |
| Product code | LZP |
| Approval date | Jan 14, 1983 |
| Docket number | 83M-0022 |
| Notice date | Feb 8, 1983 |
| Establishment registration | 3012236936 |
| FEI number | 3012236936 |
At a glance
- 10–99 Supplements
- Jul 28, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: