Cologuard
FDA premarket approval P130017/S027 · decided 2019-05-14
Approval details
- PMA number
- P130017
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cologuard
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2019-02-14
- Decision date
- 2019-05-14
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Approval for removing the restriction that the assay may only be run at the single site located at 145 E. Badger Rd., Suite 100, Madison, Wisconsin. The device, as modified, will be marketed under the trade name Cologuard. Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. Cologuard is for use with the Cologuard collection kit and the following instruments: BioTek® Epoch 2 Absorbance Micropl
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