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.
 
DeviceMI Cancer Seek
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantCaris Life Sciences
4610 S. 44th Pl.
Phoenix, AZ 85040
PMA NumberP240010
Supplement NumberS001
Date Received11/08/2024
Decision Date02/06/2025
Product Code PQP 
Advisory Committee Molecular Genetics
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedYes
Approval Order Statement  
Approval for a predetermined change control plan (PCCP) that includes minor software modifications consistent with the intended use of the assay and qualification of serial number-controlled instrument changes.
-
-