- Device
- KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S003
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2012-08-27
- Decision code
- APPR
- Date received
- 2012-05-29
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE STERILIZATION METHOD, STERRAD NX, FOR THE FLUID LIGHT CABLE DEVICE COMPONENT WITHIN THE DEVICE.