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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 | S021 |
Date Received | 05/08/2020 |
Decision Date | 06/05/2020 |
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 add a filtered air brush that uses compressed air as an alternative to canned air for cleaning the Tricam Pendulum camera head. |