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Device | Karl Storz Photodynamic 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 | S018 |
Date Received | 05/30/2019 |
Decision Date | 12/20/2019 |
Product Code |
OAY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the light output spectral analysis measuring method of the D-Light C Light Source |