PMA supplement
P830064 S002: NEODYMIUM-YAG OP LASER OPL-3
FDA PMA supplement · Coburn Optical Ind., Inc.
Key facts
| Original PMA | P830064 |
|---|---|
| Supplement number | S002 |
| Trade name | NEODYMIUM-YAG OP LASER OPL-3 |
| Generic name | Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla |
| Applicant | Coburn Optical Ind., Inc. |
| Product code | LXS |
| Received date | Nov 7, 1984 |
| Decision date | Dec 13, 1984 |
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: