PMA supplement
P990027 S021: TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System
FDA PMA supplement · Panel Track · Technolas Perfect Vision GmbH
Key facts
| Original PMA | P990027 |
|---|---|
| Supplement number | S021 |
| Supplement type | Panel Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System |
| Generic name | Excimer laser system |
| Applicant | Technolas Perfect Vision GmbH |
| Product code | LZS |
| Received date | Feb 2, 2023 |
| Decision date | Nov 22, 2023 |
| Docket number | 23M-5212 |
| Notice date | Nov 27, 2023 |
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: