- Device
- Karl Storz Photodynamic D-light C (PDD) System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S018
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2019-12-20
- Decision code
- APPR
- Date received
- 2019-05-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the light output spectral analysis measuring method of the D-Light C Light Source