FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
PMA: P150027
·
Supplement: S003
·
Decision Feb 24, 2017
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
- Trade Name
- PD-L1 IHC 28-8 PHARMDX
- PMA Number
- P150027
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- PLS
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 24, 2017
- Date Received
- August 29, 2016
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
Approval for the updated product labeling and associated data.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PLS | Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 | FDA class 3 | Unknown |