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.
 
DeviceAtellica IM Prostate-Specific Antigen (PSA)
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSiemens Healthcare Diagnostics
333 Coney St.
East Walpole, MA 02032
PMA NumberP950021
Supplement NumberS015
Date Received08/01/2017
Decision Date08/03/2018
Product Code MTF 
Advisory Committee Immunology
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 of the migration of the ADVIA Centaur PSA Assay to the Atellica IM Analyzer.
-
-