PMA
P970034: MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA PMA · Intraocular lens · Aaren Scientific
Key facts
| PMA number | P970034 |
|---|---|
| Trade name | MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES |
| Generic name | Intraocular lens |
| Applicant | Aaren Scientific |
| Owner/operator | Aaren Laboratories LLC |
| Product code | HQL |
| Approval date | Sep 25, 1998 |
| Docket number | 98M-0855 |
| Notice date | Oct 27, 1998 |
| Establishment registration | 3013202565 |
| FEI number | 3013202565 |
At a glance
- 10–99 Supplements
- Mar 12, 2010 Latest supplement decision
- Yes Withdrawn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: