FoundationFocus CDxBRCA
by Foundation Medicine, Inc. PMA
Withdrawn
PMA P160018
Regulatory status
Withdrawn since 19 Dec 2016. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP160018 | Date19 Dec 2016 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Recalls
No FDA recalls on record, checked 27 Oct 2026.
Specification
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- PMA Number
- FDA Product Code
- PQP
- Device Class
- Class III
- Advisory Committee
- Pathology
- FDA Decision
- APWD Approval withdrawn