PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
FDA premarket approval P990081/S035 · decided 2017-03-13
Approval details
- PMA number
- P990081
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2016-11-15
- Decision date
- 2017-03-13
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for software modification in the BenchMark XT from NexES to VSS 12.5 and associated hardware changes.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Roche Digital Pathology Dx (K242783) | Ventana Medical Systems, Inc. | 2024-12-17 |
| VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (DEN240025) | Ventana Medical Systems, Inc. | 2024-12-05 |
| Roche Digital Pathology Dx (VENTANA DP 200) (K232879) | Ventana Medical Systems, Inc. | 2024-06-14 |
| CINtec Histology (K212176) | Ventana Medical Systems, Inc. | 2021-12-10 |
| VENTANA CD30 (Ber-H2) RxDx Assay (K172471) | Ventana Medical Systems, Inc. | 2018-05-08 |
| CINtec Histology (50 tests), CINtec Histology (250 tests) (DEN160019) | Ventana Medical Systems, Inc. | 2017-03-04 |
| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
| VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465) | Ventana Medical Systems, Inc. | 2014-03-20 |