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 2018-12-06

Automated external defibrillators (non-wearable)

Applicant Physio-Control, Inc.

PMA Number P160026

Class 3

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PMA 2018-12-06

Automated external defibrillators (non-wearable)

Applicant ZOLL Medical Corporation

PMA Number P160034

Class 3

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PMA 2018-12-03

Valve, pulmonary

Applicant Gyrus Acmi, Inc.

PMA Number P180007

Class 3

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PMA 2018-11-30

Sensor, glucose, invasive

Applicant Medtronic Minimed

PMA Number P160007

Class 3

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PMA 2018-11-29

Automated insulin dosing , threshold suspend

Applicant Tandem Diabetes Care, Inc.

PMA Number P180008

Class 3

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PMA 2018-11-27

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Cordis US Corporation

PMA Number P150002

Class 3

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PMA 2018-11-21

System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy

Applicant Medifocus, Inc.

PMA Number P030006

Class 3

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PMA 2018-11-20

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

Applicant Abbott Laboratories

PMA Number P060035

Class 2

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PMA 2018-11-15

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Hologic, Inc.

PMA Number P080014

Class 3

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PMA 2018-11-15

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Hologic, Inc.

PMA Number P080015

Class 3

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PMA 2018-11-14

Intracranial aneurysm flow diverter

Applicant Stryker Neurovascular

PMA Number P170024

Class 3

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PMA 2018-11-09

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

Applicant Abbott Laboratories

PMA Number P080023

Class 2

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