KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
FDA premarket approval P050027/S001 · decided 2010-08-10
Approval details
- PMA number
- P050027
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
- Generic name
- Light source system, diagnostic endoscopic
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2010-06-11
- Decision date
- 2010-08-10
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.