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Device | KARL STORZ D-Light C PDD System |
Generic Name | Light source system, diagnostic endoscopic |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. EL SEGUNDO, CA 90245 |
PMA Number | P050027 |
Supplement Number | S030 |
Date Received | 02/16/2022 |
Decision Date | 03/17/2022 |
Product Code |
OAY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Manufacturing change to transfer the PDD Cystoscope Monocoil to a vertebrae weld and the PDD Cystoscope Screw Tube sub-assembly weld to be welded by the welder in the Pilot production room. |