• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 
Trade NameCOLOGUARD
Classification Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
ApplicantEXACT SCIENCES CORPORATION
PMA NumberP130017
Date Received06/07/2013
Decision Date08/11/2014
Product Code
PHP[ Registered Establishments with PHP ]
Docket Number 14M-1193
Notice Date 08/13/2014
Advisory Committee Pathology
Clinical Trials NCT01260168
NCT01397747
NCT01600209
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the cologuard. Cologuard is intended for the qualitative detection of colorectal neoplasia associated dna markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (crc) or advanced adenoma (aa) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for crc. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
-
-