PMA supplement
P850063 S001: MICRO YAG ND:YAG LASER SYSTEM
FDA PMA supplement · Sorin Group USA, Inc.
Key facts
| Original PMA | P850063 |
|---|---|
| Supplement number | S001 |
| Trade name | MICRO YAG ND:YAG LASER SYSTEM |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Sorin Group USA, Inc. |
| Product code | LOI |
| Received date | May 19, 1986 |
| Decision date | Jun 17, 1986 |
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: