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 2020-11-13

Immunocytochemistry assay, p16/Ki-67

Applicant Ventana Medical Systems, Inc.

PMA Number P190024

Class 3

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PMA 2020-11-06

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

Applicant Foundation Medicine, Inc.

PMA Number P200016

Class 3

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PMA 2020-11-05

Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Applicant Abbott Laboratories

PMA Number P980007

Class 3

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PMA 2020-11-05

Prosthesis, intervertebral disc

Applicant Nuvasive, Inc.

PMA Number P200022

Class 3

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PMA 2020-10-26

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

Applicant Foundation Medicine, Inc.

PMA Number P200006

Class 3

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PMA 2020-10-21

Stent, iliac vein

Applicant Medtronic Vascular, Inc.

PMA Number P200026

Class 3

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PMA 2020-10-09

Stent, iliac vein

Applicant Cook Ireland, Ltd.

PMA Number P200023

Class 3

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PMA 2020-09-28

Scaffold, dissection repair

Applicant Philips Image Guided Therapy Corporation (Formerly Intact)

PMA Number P190027

Class 3

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PMA 2020-08-29

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

Applicant DiaSorin, Inc.

PMA Number P180048

Class 2

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PMA 2020-08-29

Qualitative and Quantitative Hepatitis B Virus Antibody assays

Applicant DiaSorin, Inc.

PMA Number P180049

Class 2

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PMA 2020-08-29

Qualitative and Quantitative Hepatitis B Virus Antibody assays

Applicant DiaSorin, Inc.

PMA Number P180045

Class 2

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PMA 2020-08-29

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

Applicant DiaSorin, Inc.

PMA Number P190017

Class 2

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