PMA
P220009: StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
FDA PMA · AID, SURGICAL, VISCOELASTIC · Bausch Health Companies, Inc.
Key facts
| PMA number | P220009 |
|---|---|
| Trade name | StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Bausch Health Companies, Inc. |
| Owner/operator | Bausch Health US LLC |
| Product code | LZP |
| Approval date | Feb 22, 2023 |
| Docket number | 23M-0607 |
| Establishment registration | 3009443653 |
| FEI number | 3009443653 |
At a glance
- None Supplements
- Feb 22, 2023 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- No Withdrawn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: