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.
 
DeviceFoundationOne®CDx (F1CDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
400 Summer St.
Boston, MA 02210
PMA NumberP170019
Supplement NumberS052
Date Received12/19/2023
Decision Date08/30/2024
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT03732820
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval order to expand the intended use of FoundationOne CDx (F1CDx) (P170019/S052) and FoundationOne Liquid CDx (F1LCDx) (P190032/S016) to include a companion diagnostic indication to identify patients with prostate cancer with BRCA1/2 alterations for the treatment with LYNPARZA (olaparib) in combination with abiraterone.
-
-