PMA supplement
P050027 S028: KARL STORZ D-Light C PDD System
FDA PMA supplement · Normal 180 Day Track · KARL STORZ Endoscopy-America, Inc.
Key facts
| Original PMA | P050027 |
|---|---|
| Supplement number | S028 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | KARL STORZ D-Light C PDD System |
| Generic name | Light source system, diagnostic endoscopic |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Product code | OAY |
| Received date | Jul 20, 2021 |
| Decision date | Feb 4, 2022 |
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: