PMA
P010027: ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)
FDA PMA · Intraocular lens · Aaren Scientific
Key facts
| PMA number | P010027 |
|---|---|
| Trade name | ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT) |
| Generic name | Intraocular lens |
| Applicant | Aaren Scientific |
| Owner/operator | Aaren Laboratories LLC |
| Product code | HQL |
| Approval date | Nov 21, 2001 |
| Docket number | 02M-0180 |
| Notice date | May 7, 2002 |
| Establishment registration | 3013202565 |
| FEI number | 3013202565 |
At a glance
- 1–9 Supplements
- Mar 2, 2012 Latest supplement decision
- Yes Withdrawn
- Yes 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: