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 2022-12-23

Extended depth of focus intraocular lens

Applicant Acu Focus, Inc.

PMA Number P210005

Class 3

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PMA 2022-12-21

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant W. L. Gore & Associates, Inc.

PMA Number P210032

Class 3

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PMA 2022-12-20

Mitral valve repair devices

Applicant Edwards Lifesciences, LLC

PMA Number P220003

Class 3

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PMA 2022-12-20

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P210019

Class 2

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PMA 2022-12-12

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

Applicant Exact Sciences Corporation

PMA Number P210040

Class 3

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PMA 2022-12-07

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Abbott Laboratories

PMA Number P210003

Class 2

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PMA 2022-11-30

Stimulator, tibial, electrical, implantable, for urinary incontinence

Applicant Boston Scientific Corporation

PMA Number P200036

Class 3

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PMA 2022-11-28

Cytomegalovirus (cmv) dna quantitative assay

Applicant Abbott Molecular, Inc.

PMA Number P210022

Class 2

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PMA 2022-11-23

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant Biosense Webster, Inc.

PMA Number P210027

Class 3

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PMA 2022-11-17

Lens, multifocal intraocular

Applicant Lenstec, Inc.

PMA Number P200020

Class 3

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PMA 2022-11-14

Immunohistochemistry Assay, Antibody, FOLR1

Applicant Ventana Medical Systems, Inc.

PMA Number P220006

Class 3

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PMA 2022-11-04

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Applicant Trireme Medical, LLC

PMA Number P210039

Class 3

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