PMA P050027S020
- Device
- KARL STORZ Photodynamic Diagnostic D-Light C System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S020
- Product code
- OAY
- Decision date
- 2020-03-25
- Generic name
- Light source system, diagnostic endoscopic
- Approval order statement
- Process change to change the weld program and laser welder.
Current openFDA PMA Record#
- Device
- KARL STORZ Photodynamic Diagnostic D-Light C System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S020
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2020-03-25
- Decision code
- OK30
- Date received
- 2020-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process change to change the weld program and laser welder.