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 | S003 |
Date Received | 05/29/2012 |
Decision Date | 08/27/2012 |
Product Code |
OAY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE STERILIZATION METHOD, STERRAD NX, FOR THE FLUID LIGHT CABLE DEVICE COMPONENT WITHIN THE DEVICE. |
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