PMA supplement
P980006 S004: PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
FDA PMA supplement · Panel Track · Bausch & Lomb, Inc.
Key facts
| Original PMA | P980006 |
|---|---|
| Supplement number | S004 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Bausch & Lomb, Inc. |
| Product code | LPM |
| Received date | May 30, 2001 |
| Decision date | Nov 20, 2001 |
| Docket number | 01M-0531 |
| Notice date | Nov 29, 2001 |
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: