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. |
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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 | S013 |
Date Received | 07/20/2018 |
Decision Date | 10/23/2018 |
Product Code |
OAY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the following alternate sterilization methods for the PDD Camera Heads: STERRAD NX Standard Cycle, STERRAD 100 NX Standard and Duo Cycles, V-Pro 60 Non-Lumen and Lumen Cycles. |
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