PMA
P900048: ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM
FDA PMA · Intraocular lens · Staar Surgical Co.
Key facts
| PMA number | P900048 |
|---|---|
| Trade name | ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM |
| Generic name | Intraocular lens |
| Applicant | Staar Surgical Co. |
| Owner/operator | STAAR SURGICAL Company |
| Product code | HQL |
| Approval date | Sep 17, 1991 |
| Docket number | 91M-0376 |
| Notice date | Oct 11, 1991 |
| Establishment registration | 2023826 |
| FEI number | 2023826 |
At a glance
- 1–9 Supplements
- Aug 23, 1993 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: