FoundationOne®Liquid CDx
FDA premarket approval P200006/S002 · decided 2022-09-21
Approval details
- PMA number
- P200006
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne®Liquid CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2022-08-22
- Decision date
- 2022-09-21
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for the formatting and updates to the Specimen Instructions document, the technical labeling, and the mock patient reports for FoundationOne® Liquid CDx.
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