PMA P050027S031
- Device
- KARL STORZ D-Light C PDD System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S031
- Product code
- OAY
- Decision date
- 2023-05-05
- Classification
- Gastroenterology, Urology
- Generic name
- Light source system, diagnostic endoscopic
- Approval order statement
- Change in supplier of three subassembly components used in the Karl Storz PDD System.
Current openFDA PMA Record#
- Device
- KARL STORZ D-Light C PDD System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S031
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2023-05-05
- Decision code
- OK30
- Date received
- 2023-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in supplier of three subassembly components used in the Karl Storz PDD System.