PMA supplement
P060022 S006: AKREOS ADVANCED OPTICS ASPHERIC LENS AND AKROES AO MICRO INCISION LENS
FDA PMA supplement · Real-Time Process · Bausch & Lomb, Inc.
Key facts
| Original PMA | P060022 |
|---|---|
| Supplement number | S006 |
| Supplement type | Real-Time Process |
| Trade name | AKREOS ADVANCED OPTICS ASPHERIC LENS AND AKROES AO MICRO INCISION LENS |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb, Inc. |
| Product code | HQL |
| Received date | Jan 29, 2010 |
| Decision date | Apr 1, 2010 |
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: