PMA
P960028: AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
FDA PMA · Lens, multifocal intraocular · Johnson & Johnson Surgical Vision, Inc.
Key facts
| PMA number | P960028 |
|---|---|
| Trade name | AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic name | Lens, multifocal intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Owner/operator | Johnson & Johnson Surgical Vision, Inc. |
| Product code | MFK |
| Approval date | Sep 5, 1997 |
| Docket number | 97M-0499 |
| Notice date | Dec 9, 1997 |
| Establishment registration | 3012236936 |
| FEI number | 3012236936 |
At a glance
- 10–99 Supplements
- Oct 27, 2017 Latest supplement decision
- No Withdrawn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: