Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA Approvals

Premarket Approval devices tracked by MedTracker

PMA 2026-08-26

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P240021

Class 3

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PMA 2026-08-26

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Applicant Freenome, LLC

PMA Number P250029

Class 3

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PMA 2026-08-25

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P960040

Class 3

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PMA 2026-08-25

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant Boston Scientific Corp

PMA Number P010012

Class 3

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PMA 2026-08-25

SYSTEM, TEST, HER-2/NEU, IHC

Applicant Ventana Medical Systems, Inc.

PMA Number P990081

Class 3

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PMA 2026-08-25

Automated external defibrillators (non-wearable)

Applicant Defibtech, LLC

PMA Number P160032

Class 3

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PMA 2026-08-25

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Applicant Ventana Medical Systems, Inc.

PMA Number P190031

Class 2

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PMA 2026-08-21

Pump, infusion, implanted, programmable

Applicant Medtronic, Inc.

PMA Number P860004

Class 3

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PMA 2026-08-21

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Boston Scientific Corporation

PMA Number P140028

Class 3

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PMA 2026-08-21

Coronary drug-eluting stent

Applicant Boston Scientific Corporation

PMA Number P150003

Class 3

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PMA 2026-08-21

STENT, ILIAC

Applicant Boston Scientific Corp

PMA Number P110035

Class 3

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PMA 2026-08-21

DEVICE, ANGIOPLASTY, LASER, CORONARY

Applicant Spectranetics Corp.

PMA Number P910001

Class 3

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