PMA P050027S011
- Device
- Karl Storz D-Light C PDD System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S011
- Product code
- OAY
- Decision date
- 2018-02-15
- Classification
- Light Source System, Diagnostic Endoscopic
- Generic name
- Light source system, diagnostic endoscopic
- Approval order statement
- Approval for additional subsystem and manufacturing site.
Current openFDA PMA Record#
- Device
- Karl Storz D-Light C PDD System
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S011
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2018-02-15
- Decision code
- APPR
- Date received
- 2017-08-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for additional subsystem and manufacturing site.