PMA supplement
P010019 S003: O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
FDA PMA supplement · Normal 180 Day Track · Alcon Laboratories, Inc.
Key facts
| Original PMA | P010019 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Alcon Laboratories, Inc. |
| Product code | LPM |
| Received date | Jun 8, 2004 |
| Decision date | Sep 27, 2004 |
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: