FoundationOne CDx
FDA premarket approval P170019/S006 · decided 2019-12-03
Approval details
- PMA number
- P170019
- Supplement
- S006
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FoundationOne CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2018-12-26
- Decision date
- 2019-12-03
- Days to decision
- 342 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval order for extending the label claim to include an indication for PIQRAY (alpelisib) in breast cancer patients with PIK3CA C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y alterations.
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