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 | BD Totalys MultiProcessor |
Generic Name | Processor, cervical cytology slide, automated |
Applicant | BD Diagnostic Systems 4025 STIRRUP CREEK DRIVE SUITE 400 DURHAM, NC 27703 |
PMA Number | P970018 |
Supplement Number | S039 |
Date Received | 09/24/2021 |
Decision Date | 12/21/2021 |
Product Code |
MKQ |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the minor design changes to the BD Totalys MultiProcessor electronic hardware components, process deck cover, and software modifications to support changes in reagent/waste capacity, operating system, batch types, and service tools. |
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