PMA
P000046: STAARVISC II
FDA PMA · AID, SURGICAL, VISCOELASTIC · Anika Therapeutics, Inc.
Key facts
| PMA number | P000046 |
|---|---|
| Trade name | STAARVISC II |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Anika Therapeutics, Inc. |
| Owner/operator | ANIKA THERAPEUTICS, INC. |
| Product code | LZP |
| Approval date | Apr 18, 2001 |
| Docket number | 01M-0227 |
| Notice date | May 14, 2001 |
| Establishment registration | 3007093114 |
| FEI number | 3007093114 |
At a glance
- 10–99 Supplements
- Aug 28, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: