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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 NumberS022
Date Received05/08/2020
Decision Date08/17/2020
Product Code OAY 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for increase in the tolerance of the countersink angle of the outer shell of the Grasping Mechanism of the Tricam camera heads from 82 +/-I degree to 82 +7/-3 degrees.
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