PMA supplement
P880081 S023: MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS
FDA PMA supplement · Real-Time Process · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Original PMA | P880081 |
|---|---|
| Supplement number | S023 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS |
| Generic name | Intraocular lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product code | HQL |
| Received date | Jun 30, 1997 |
| Decision date | Oct 2, 1997 |
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: