PMA supplement
P990027 S020: TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALI
FDA PMA supplement · 30-Day Notice · Technolas Perfect Vision GmbH
Key facts
| Original PMA | P990027 |
|---|---|
| Supplement number | S020 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALI |
| Generic name | Excimer laser system |
| Applicant | Technolas Perfect Vision GmbH |
| Product code | LZS |
| Received date | Oct 7, 2015 |
| Decision date | Nov 5, 2015 |
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: