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 2020-08-29

Hepatitis Viral B DNA Detection

Applicant Abbott Molecular, Inc.

PMA Number P200013

Class 2

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PMA 2020-08-26

Somatic gene mutation detection system

Applicant Roche Molecular System, Inc.

PMA Number P200014

Class 3

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PMA 2020-08-26

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

Applicant Foundation Medicine, Inc.

PMA Number P190032

Class 3

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PMA 2020-08-13

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

Applicant DiaSorin, Inc.

PMA Number P180038

Class 2

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PMA 2020-08-13

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

Applicant DiaSorin, Inc.

PMA Number P180039

Class 2

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PMA 2020-08-11

Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test

Applicant Oxford Immunotec, Ltd.

PMA Number P070006

Class 3

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PMA 2020-08-07

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

Applicant Guardant Health, Inc.

PMA Number P200010

Class 3

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PMA 2020-08-07

Automated external defibrillators (non-wearable)

Applicant Cardinalhealth

PMA Number P190007

Class 3

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PMA 2020-07-24

Fluid, intraocular

Applicant Alcon Laboratories

PMA Number P950018

Class 3

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PMA 2020-06-16

Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief

Applicant Mainstay Medical Limited

PMA Number P190021

Class 3

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PMA 2020-06-09

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

Applicant Abbott Molecular, Inc.

PMA Number P190025

Class 2

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PMA 2020-06-07

Acid, hyaluronic, intraarticular

Applicant Channel-Markers Medical, LLC

PMA Number P140005

Class 3

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