PMA P050027S012
- Device
- Karl Storz Photodynamic D-Light C (PDD) System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S012
- Product code
- OAY
- Decision date
- 2018-05-22
- Classification
- Light Source System, Diagnostic Endoscopic
- Generic name
- Light source system, diagnostic endoscopic
- Approval order statement
- Relocation of manufacturing of flexible cystoscope subassemblies.
Current openFDA PMA Record#
- Device
- Karl Storz Photodynamic D-Light C (PDD) System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S012
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2018-05-22
- Decision code
- OK30
- Date received
- 2018-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of manufacturing of flexible cystoscope subassemblies.