PMA P230011S004
- Device
- TruSight Oncology Comprehensive
- Applicant
- Illumina, Inc.
- PMA number
- P230011
- Supplement
- S004
- Product code
- PQP
- Decision date
- 2025-09-05
- Classification
- Pathology
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- manufacturing process changes
Current openFDA PMA Record#
- Device
- TruSight Oncology Comprehensive
- Applicant
- Illumina, Inc.
- PMA number
- P230011
- Supplement
- S004
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2025-09-05
- Decision code
- OK30
- Date received
- 2025-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing process changes