|
Device | BD FOCALPOINT SLIDE PROFILER |
Generic Name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
Applicant | BD DIAGNOSTICS 4025 STIRRUP CREEK DRIVE SUITE 400 DURHAM, NC 27703 |
PMA Number | P950009 |
Supplement Number | S013 |
Date Received | 09/15/2011 |
Decision Date | 11/10/2011 |
Product Code |
MNM |
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 SOFTWARE CHANGES TO THE BD FOCALPOINT SLIDE PROFILER FROM THE CURRENT PRODUCTION VERSION APPS 3.4.1A TO APPS 3.5.0. |