PMA P170019S008
- Device
- FoundationOne CDx (F1CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S008
- Product code
- PQP
- Decision date
- 2019-07-01
- Classification
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Approval order for extending the label claim to include an indication for TAGRISSO (osimertinib) in non-small cell lung cancer patients with EGFR exon 19 deletions and EGFR exon 21 L858R alterations.
Current openFDA PMA Record#
- Device
- FoundationOne CDx (F1CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S008
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2019-07-01
- Decision code
- APPR
- Date received
- 2019-04-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval order for extending the label claim to include an indication for TAGRISSO (osimertinib) in non-small cell lung cancer patients with EGFR exon 19 deletions and EGFR exon 21 L858R alterations.