PMA P050027S032
- Device
- KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S032
- Product code
- OAY
- Decision date
- 2024-09-27
- Classification
- Gastroenterology, Urology
- Generic name
- Light source system, diagnostic endoscopic
- Approval order statement
- a change to the sub-assemblies component manufacturing location for FEI # 2027009 components
Current openFDA PMA Record#
- Device
- KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S032
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2024-09-27
- Decision code
- OK30
- Date received
- 2024-09-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the sub-assemblies component manufacturing location for FEI # 2027009 components