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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 | S022 |
Date Received | 05/08/2020 |
Decision Date | 08/17/2020 |
Product Code |
OAY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |