PMA supplement
P080004 S046: iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231 & IPure™ Preloaded IOL System/ Model B1PC (Clear
FDA PMA supplement · 135 Review Track For 30-Day Notice · Hoya Surgical Optics, Inc.
Key facts
| Original PMA | P080004 |
|---|---|
| Supplement number | S046 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231 & IPure™ Preloaded IOL System/ Model B1PC (Clear |
| Generic name | Intraocular lens |
| Applicant | Hoya Surgical Optics, Inc. |
| Product code | HQL |
| Received date | Dec 2, 2022 |
| Decision date | May 4, 2023 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: