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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameKARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
Classification Namelight source system, diagnostic endoscopic
Generic Namephotodynamic diagnosis system
ApplicantKARL STORZ ENDOSCOPY-AMERICA, INC.
PMA NumberP050027
Supplement NumberS001
Date Received06/11/2010
Decision Date08/10/2010
Product Code
OAY[ Registered Establishments with OAY ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason design change - minor
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.
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