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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceKARL STORZ PHOTODYNAMIC 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
Supplement NumberS003
Date Received05/29/2012
Decision Date08/27/2012
Product Code OAY 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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