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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.
 
Trade NameKARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
Classification Namelight source system, diagnostic endoscopic
Generic Namephotodynamic diagnosis system
ApplicantKARL STORZ ENDOSCOPY-AMERICA, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the karl storz photodynamic diagnostic d-light c (pdd) system. The karl storz photodynamic diagnostic d-light c (pdd) system in combination with the optical imaging drug cysview (hexaminolevulinate hydrochloride) for intravesical solution is indicated for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive papillary cancer of the bladder in patients suspected or known to have the lesion on the basis of a prior cystoscopy.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 
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