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 2020-01-23

Stimulator, bone growth, non-invasive

Applicant Djo, LLC

PMA Number P910066

Class 3

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PMA 2019-12-19

Pump, infusion, insulin, to be used with invasive glucose sensor

Applicant Tandem Diabetes Care, Inc.

PMA Number P140015

Class 3

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PMA 2019-12-19

Automated insulin dosing , threshold suspend

Applicant Tandem Diabetes Care, Inc.

PMA Number P180008

Class 3

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PMA 2019-11-21

heart-valve, non-allograft tissue

Applicant Corcym Canada Corp

PMA Number P060038

Class 3

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PMA 2019-11-04

implanted diaphragmatic/phrenic nerve Stimulator

Applicant Avery Biomedical Devices, Inc.

PMA Number P860026

Class 3

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PMA 2019-10-11

Placental alpha microglobulin-1 immunoassay

Applicant Qiagen, Inc.

PMA Number P160052

Class 3

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PMA 2019-09-10

Lenses, soft contact, extended wear

Applicant CooperVision, Inc.

PMA Number P780007

Class 3

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PMA 2019-09-05

Analyzer, medical image

Applicant Carestream Dental, LLC

PMA Number P980025

Class 2

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PMA 2019-08-21

heart-valve, non-allograft tissue

Applicant Medtronic, Inc.

PMA Number P060025

Class 3

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PMA 2019-08-14

Sensor, glucose, invasive

Applicant Medtronic Minimed

PMA Number P980022

Class 3

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PMA 2019-06-19

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

Applicant Ortho-Clinical Diagnostics, Inc.

PMA Number P000044

Class 2

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PMA 2019-06-19

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

Applicant Ortho-Clinical Diagnostics

PMA Number P030024

Class 2

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