PMA supplement
P030002 S027: TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
FDA PMA supplement · Panel Track · Bausch & Lomb, Inc.
Key facts
| Original PMA | P030002 |
|---|---|
| Supplement number | S027 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic name | LENS, INTRAOCULAR, TORIC OPTICS |
| Applicant | Bausch & Lomb, Inc. |
| Product code | MJP |
| Received date | Mar 27, 2012 |
| Decision date | May 20, 2013 |
| Docket number | 13M-0724 |
| Notice date | Jun 18, 2013 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: