PMA P050027S001
- Device
- KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S001
- Product code
- OAY
- Decision date
- 2010-08-10
- Classification
- Light Source System, Diagnostic Endoscopic
- Generic name
- Light source system, diagnostic endoscopic
- Approval order statement
- APPROVAL FOR: 1) REPLACEMENT OF THE EXISTING KARL STORZ CAMERA CONTROL UNIT (CCU), TRADE NAME ¿TRICAM SL,¿ WITH A NEW MODEL TO BE MARKETED UNDER THE TRADE NAME ¿TRICAM SL II¿; AND 2) MINOR LABELING CHANGES TO REFLECT THE CHANGE IN THE CCU TRADE NAME.
Current openFDA PMA Record#
- Device
- KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S001
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2010-08-10
- Decision code
- APPR
- Date received
- 2010-06-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR: 1) REPLACEMENT OF THE EXISTING KARL STORZ CAMERA CONTROL UNIT (CCU), TRADE NAME ¿TRICAM SL,¿ WITH A NEW MODEL TO BE MARKETED UNDER THE TRADE NAME ¿TRICAM SL II¿; AND 2) MINOR LABELING CHANGES TO REFLECT THE CHANGE IN THE CCU TRADE NAME.