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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 NumberS004
Date Received08/21/2012
Decision Date09/10/2012
Product Code
OAY[ Registered Establishments with OAY ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval of corrections to the ethylene oxide (eto) sterilization instructions contained in the pdd camera heads instruction card, hopkins ii pdd telescopes instruction manual and tricam sl ii camera control unit instruction manual.
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