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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 NumberS003
Date Received05/30/2012
Decision Date08/27/2012
Product Code
OAY[ Registered Establishments with OAY ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization method, sterrad nx, for the fluid light cable device component within the device.
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