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 2021-12-17

Wearable automated external defibrillator

Applicant Kestra Medical Technologies, Inc.

PMA Number P200037

Class 3

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PMA 2021-12-16

Aortic valve, prosthesis, percutaneously delivered

Applicant ABBOTT MEDICAL

PMA Number P190023

Class 3

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PMA 2021-12-16

Pulmonary valve prosthesis percutaneously delivered

Applicant Medtronic, Inc.

PMA Number P200046

Class f

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PMA 2021-12-16

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

Applicant Roche Diagnostics

PMA Number P190034

Class 2

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PMA 2021-12-13

Coronary drug-eluting stent

Applicant Advanced Bifurcation Systems, Inc.

PMA Number P210014

Class 3

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PMA 2021-12-09

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation

Applicant Organox Limited

PMA Number P200035

Class 3

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PMA 2021-12-09

System, appendage closure, left atrial

Applicant ABBOTT MEDICAL

PMA Number P200049

Class 3

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PMA 2021-12-07

Multi-analyte test system with algorithmic analysis for detection of prostate cancer

Applicant Opko Health, Inc.

PMA Number P190022

Class 3

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PMA 2021-12-03

Catheter, Balloon, Urethral, Drug-Coated

Applicant Urotronic, Inc.

PMA Number P210020

Class 3

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PMA 2021-11-17

Combination compression/decompression manual chest pump with impedance respiratory valve

Applicant ZOLL Medical Corporation

PMA Number P110024

Class 3

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PMA 2021-11-16

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Bolton Medical, Inc.

PMA Number P200045

Class 3

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PMA 2021-11-08

Implant, cochlear

Applicant Oticon Medical

PMA Number P200021

Class 3

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