- Device
- KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S009
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2017-11-30
- Decision code
- APPR
- Date received
- 2017-06-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes in cable assembly and solder used in printed circuit board for Photodynamic D-Light Camera Heads and Camera Control Unit.