FoundationOne Liquid CDx
FDA premarket approval P200006/S001 · decided 2022-02-03
Approval details
- PMA number
- P200006
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- FoundationOne Liquid CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2021-03-23
- Decision date
- 2022-02-03
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval of the clinical protocol entitled Statistical Analysis Plan Expanded Validation Study for the Efficacy of Rucaparib in Ovarian Cancer based on F1L CDx.
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