PMA supplement
P960028 S011: SOFT ACRYLIC MULTIFOCAL ARRAY 2 (MODELS AA40E AND AA50) AND REZOOM (MODEL NXG1) INTRAOCULAR LENSES
FDA PMA supplement · Normal 180 Day Track · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Original PMA | P960028 |
|---|---|
| Supplement number | S011 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | SOFT ACRYLIC MULTIFOCAL ARRAY 2 (MODELS AA40E AND AA50) AND REZOOM (MODEL NXG1) INTRAOCULAR LENSES |
| Generic name | Lens, multifocal intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product code | MFK |
| Received date | Oct 4, 2004 |
| Decision date | Mar 23, 2005 |
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: