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FDA PMA

Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN)

PMA Number: P250031 · 2026-06-12

ApplicantVentana Medical Systems, Inc. (Roche Tissue Diagnostics)
Decision Date2026-06-12
PMA NumberP250031
Product CodeSHF
Advisory CommitteePA

Device Summary

Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN) is the device name listed in this FDA PMA record. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). It received FDA Premarket Approval (PMA) on 2026-06-12 under PMA number P250031. The device is classified under FDA product code SHF. It was reviewed by the PA advisory panel. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN)?

Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN) is a medical device that received FDA Premarket Approval (PMA) on 2026-06-12. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). The PMA number is P250031.

When did Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN) receive FDA PMA approval?

Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN) received FDA PMA approval on 2026-06-12, under PMA number P250031.

Who is the listed applicant for Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN)?

The FDA PMA record lists Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) as the applicant. This does not by itself establish the device manufacturer.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN)?

The FDA product code for Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN) is SHF.

Other records listing Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P210001Immunohistochemistry test, DNA mismatch repair (MMR) Protein assayPMA P240037Immunohistochemistry Assay, Antibody, MET

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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