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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceKARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
Classification Namelight source system, diagnostic endoscopic
Generic Namelight source system, diagnostic endoscopic
Applicant
KARL 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[ Registered Establishments with OAY ]
Docket Number 10M-0294
Notice Date 06/14/2010
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 
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