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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 DIAGNOSTIC 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 NumberS014
Date Received09/17/2018
Decision Date02/21/2019
Product Code OAY 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following alternate sterilization methods for the Flexible PDD Video Cystoscopes (P/N: 11272VNIA and 11272VNIUA): STERRAD NX Advanced Cycle, STERRAD 100 NX Flex and Duo Cycles, STERIS V-PRO maX Flexible Cycle and Steris V-PRO 60 Flexible Cycle.
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