PMA
P050027: KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
FDA PMA · Light source system, diagnostic endoscopic · KARL STORZ Endoscopy-America, Inc.
Key facts
| PMA number | P050027 |
|---|---|
| Trade name | KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM |
| Generic name | Light source system, diagnostic endoscopic |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Owner/operator | KARL STORZ SE & CO KG |
| Product code | OAY |
| Approval date | May 28, 2010 |
| Docket number | 10M-0294 |
| Notice date | Jun 14, 2010 |
| Establishment registration | 3010202439 |
| FEI number | 3007475226 |
At a glance
- 10–99 Supplements
- Jul 21, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: