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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceKARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
Generic NameLight source system, diagnostic endoscopic
ApplicantKARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVE.
EL SEGUNDO, CA 90245
PMA NumberP050027
Date Received07/31/2005
Decision Date05/28/2010
Product Code OAY 
Docket Number 10M-0294
Notice Date 06/14/2010
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE KARL STORZPHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM. THE KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHTC (PDD) SYSTEM IN COMBINATION WITH THE OPTICAL IMAGING DRUG CYSVIEW(HEXAMINOLEVULINATE HYDROCHLORIDE) FOR INTRAVESICAL SOLUTION IS INDICATED FOR PHOTODYNAMIC BLUELIGHT CYSTOSCOPY, AS AN ADJUNCT TO WHITE LIGHT CYSTOSCOPY FOR THE DETECTION OF NON-MUSCLE INVASIVEPAPILLARY CANCER OF THE BLADDER IN PATIENTS SUSPECTED OR KNOWN TO HAVE THE LESION ON THE BASIS OF A PRIOR CYSTOSCOPY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 
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