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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 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 NumberS029
Date Received09/09/2021
Decision Date10/13/2021
Product Code OAY 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Change in an epoxy manufacturing material used in the manufacturing process of the transformer in the Telecam and Tricam.
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