PMA P170019S012
- Device
- FoundationOne CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S012
- Product code
- PQP
- Decision date
- 2019-11-06
- 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 for adding fixed text language to the first page of the patient report indicating for Microsatellite Instability (MSI) results, confirmatory testing using a validated orthogonal method should be performed.
Current openFDA PMA Record#
- Device
- FoundationOne CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S012
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2019-11-06
- Decision code
- APPR
- Date received
- 2019-10-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for adding fixed text language to the first page of the patient report indicating for Microsatellite Instability (MSI) results, confirmatory testing using a validated orthogonal method should be performed.