oncoRevealTM CDx
FDA premarket approval P200011/S001 · decided 2024-04-18
Approval details
- PMA number
- P200011
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- oncoRevealTM CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Pillar Biosciences
- Date received
- 2022-07-11
- Decision date
- 2024-04-18
- Days to decision
- 647 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Natick, MA
- Statement
- This supplement is being approved for the oncoReveal CDx to expand the intended use and indication for use of oncoReveal CDx to include tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for previously diagnosed cancer patients with solid malignant neoplasms.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.