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 PREPSTAIN SYSTEM
Generic NameProcessor, cervical cytology slide, automated
ApplicantBd Diagnostic Systems
4025 Stirrup Creek Dr., Suite 400
Durham, NC 27703
PMA NumberP970018
Supplement NumberS032
Date Received03/26/2015
Decision Date02/12/2016
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the BD Totalys™ MultiProcessor, a new cell enrichment system, and the BD SurePath™ collection vial.
-
-