- Device
- KARL STORZ Photodynamic D-Light C PDD System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S024
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2020-08-17
- Decision code
- APPR
- Date received
- 2020-05-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updating the tolerances on the 6100042200 plate (#212770) and changing the raw material on the Z09170 (shaft adapter) from 304 SS to 303 SS (#213303).