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Device | KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM |
Generic Name | Light source system, diagnostic endoscopic |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. EL SEGUNDO, CA 90245 |
PMA Number | P050027 |
Supplement Number | S001 |
Date Received | 06/11/2010 |
Decision Date | 08/10/2010 |
Product Code |
OAY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
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. |