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 2021-04-20

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant OraSure Technologies, Inc.

PMA Number P080027

Class 2

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PMA 2021-04-02

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant Boston Scientific

PMA Number P950001

Class 3

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PMA 2021-04-02

implantable pacemaker Pulse-generator

Applicant Boston Scientific

PMA Number P940031

Class 3

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PMA 2021-04-02

Implantable pulse generator, pacemaker (non-CRT)

Applicant Boston Scientific

PMA Number P840068

Class 3

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PMA 2021-04-02

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P890061

Class 3

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PMA 2021-04-02

Implantable pulse generator, pacemaker (non-CRT)

Applicant Boston Scientific

PMA Number P830026

Class 3

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PMA 2021-03-30

Aortic valve, prosthesis, percutaneously delivered

Applicant Boston Scientific Corporation

PMA Number P180029

Class 3

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PMA 2021-03-24

Coronary drug-eluting stent

Applicant Abbott Vascular, Inc.

PMA Number P070015

Class 3

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PMA 2021-03-23

AID, SURGICAL, VISCOELASTIC

Applicant Bausch Health

PMA Number P200025

Class 3

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PMA 2021-03-19

Aortic valve, prosthesis, percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P130009

Class 3

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PMA 2021-03-11

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

Applicant Siemens Healthcare Diagnostics

PMA Number P030049

Class 2

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PMA 2021-03-05

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

Applicant Abbott Molecular, Inc.

PMA Number P100017

Class 2

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