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 2020-07-21

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

Applicant Hologic, Inc.

PMA Number P160023

Class 2

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PMA 2020-07-17

Prosthesis, hip, semi-constrained, metal/metal, resurfacing

Applicant Corin USA

PMA Number P050016

Class 3

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PMA 2020-05-26

Test, urea adult and pediatric (breath),

Applicant Meridian Bioscience, Inc.

PMA Number P100025

Class 3

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PMA 2020-05-05

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Nuvectra Corporation

PMA Number P130028

Class 3

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PMA 2020-04-24

Aspiration therapy system

Applicant Aspire Bariatrics, Inc.

PMA Number P150024

Class 3

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PMA 2020-04-09

Intraocular pressure lowering implant

Applicant Alcon Research, Ltd.

PMA Number P150037

Class 3

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PMA 2020-04-09

STENT, CORONARY

Applicant Medinol, Ltd.

PMA Number P110004

Class 3

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PMA 2020-03-18

Prosthesis, intervertebral disc

Applicant Companion Spine France Sas

PMA Number P060023

Class 3

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PMA 2020-03-01

Automated external defibrillators (non-wearable)

Applicant ZOLL Medical Corporation

PMA Number P160034

Class 3

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PMA 2020-02-07

Pump, infusion, implanted, programmable

Applicant Intera Oncology

PMA Number P800036

Class 3

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PMA 2020-02-05

Generator, shock-wave, for pain relief

Applicant Storz Medical AG

PMA Number P080028

Class 3

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PMA 2020-01-23

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant W. L. Gore & Associates, Inc.

PMA Number P160004

Class 3

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