PMA P050027S034
- Device
- Photodynamic Diagnostic D-Light C System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S034
- Product code
- OAY
- Decision date
- 2025-10-01
- Classification
- Gastroenterology, Urology
- Generic name
- Light source system, diagnostic endoscopic
- Approval order statement
- to replace the backside mirror coating from RSM 3950100 to RSM 3950108
Current openFDA PMA Record#
- Device
- Photodynamic Diagnostic D-Light C System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S034
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2025-10-01
- Decision code
- OK30
- Date received
- 2025-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to replace the backside mirror coating from RSM 3950100 to RSM 3950108