Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 2024-11-22

Prosthesis, breast, noninflatable, internal, silicone gel-filled

Applicant Motiva USA, LLC

PMA Number P230005

Class 3

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PMA 2024-11-20

Stent, carotid

Applicant MicroVention, Inc.

PMA Number P210030

Class 3

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PMA 2024-11-15

Stent, carotid

Applicant Contego Medical, Inc.

PMA Number P240009

Class 3

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PMA 2024-11-12

Stimulator, bone growth, non-invasive

Applicant Xstim, Inc.

PMA Number P230025

Class 3

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PMA 2024-11-08

Aortic stent

Applicant Renata Medical, Inc.

PMA Number P240003

Class 3

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PMA 2024-11-07

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Illumina, Inc.

PMA Number P230011

Class 3

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PMA 2024-11-06

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Applicant Biosense Webster, Inc.

PMA Number P240006

Class 3

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PMA 2024-11-05

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Caris Life Sciences

PMA Number P240010

Class 3

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PMA 2024-10-24

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Applicant Farapulse, Inc.

PMA Number P230030

Class 3

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PMA 2024-10-18

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Applicant Guardant Health, Inc.

PMA Number P230009

Class 3

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PMA 2024-10-18

Immunohistochemistry assay, antibody, claudin 18

Applicant Ventana Medical Systems, Inc.

PMA Number P230018

Class 3

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PMA 2024-10-15

Electrical tumor treatment fields for non-small cell lung cancer

Applicant Novocure, GmbH

PMA Number P230042

Class 3

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