PMA
P990013: COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
FDA PMA · Intraocular lens · Starr Surgical Co.
Key facts
| PMA number | P990013 |
|---|---|
| Trade name | COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic name | Intraocular lens |
| Applicant | Starr Surgical Co. |
| Owner/operator | STAAR SURGICAL Company |
| Product code | HQL |
| Approval date | Apr 2, 2000 |
| Docket number | 00M-1230 |
| Establishment registration | 2023826 |
| FEI number | 2023826 |
At a glance
- 10–99 Supplements
- Jul 19, 2021 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- No Withdrawn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: