PMA P230011S007
- Device
- TruSight Oncology Comprehensive
- Applicant
- Illumina, Inc.
- PMA number
- P230011
- Supplement
- S007
- Product code
- PQP
- Decision date
- 2026-04-23
- Classification
- Pathology
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Labeling changes updating troubleshooting instructions.
Current openFDA PMA Record#
- Device
- TruSight Oncology Comprehensive
- Applicant
- Illumina, Inc.
- PMA number
- P230011
- Supplement
- S007
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2026-04-23
- Decision code
- APPR
- Date received
- 2026-03-27
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Labeling changes updating troubleshooting instructions.