PMA supplement
P850083 S008: VISULAS ND:YAG LASER
FDA PMA supplement · Normal 180 Day Track · Carl Zeiss, Inc.
Key facts
| Original PMA | P850083 |
|---|---|
| Supplement number | S008 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | VISULAS ND:YAG LASER |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Carl Zeiss, Inc. |
| Product code | LOI |
| Received date | Sep 21, 1988 |
| Decision date | Aug 2, 1989 |
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: