PMA
P200025: ClearVisc Ophthalmic Viscosurgical Device (OVD)
FDA PMA · AID, SURGICAL, VISCOELASTIC · Bausch Health
Key facts
| PMA number | P200025 |
|---|---|
| Trade name | ClearVisc Ophthalmic Viscosurgical Device (OVD) |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Bausch Health |
| Owner/operator | Bausch Health US LLC |
| Product code | LZP |
| Approval date | Mar 23, 2021 |
| Establishment registration | 3009443653 |
| FEI number | 3009443653 |
At a glance
- None Supplements
- Mar 23, 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- No Withdrawn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: