| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
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| Generic Name | SYSTEM, TEST, HER-2/NEU, IHC |
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| Applicant | Ventana Medical Systems, Inc.
1910 E Innovation Park Dr.
Tucso, AZ 85755 |
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| PMA Number | P990081 |
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| Supplement Number | S059 |
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| Date Received | 08/15/2025 |
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| Decision Date | 12/15/2025 |
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| Product Code |
MVC |
| Advisory Committee |
Pathology |
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| Clinical Trials | NCT04784715
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
This 180-day supplement is to expand labeling of the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay for use as a companion diagnostic to identify patients with HER2-positive, advanced or metastatic breast cancer who may be eligible for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with PERJETA (pertuzumab) as first-line treatment. |
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