Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceBD FOCALPOINT SLIDE PROFILER
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantBd Diagnostics
4025 Stirrup Creek Dr., Suite 400
Durham, NC 27703
PMA NumberP950009
Supplement NumberS013
Date Received09/15/2011
Decision Date11/10/2011
Product Code MNM 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
-
-