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 2017-10-11

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P930027

Class 3

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PMA 2017-10-02

Implant, dermal, for aesthetic use

Applicant Prollenium Medical Technologies, Inc.

PMA Number P160042

Class 3

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PMA 2017-09-20

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Lombard Medical Limited

PMA Number P110032

Class 3

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PMA 2017-09-19

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG

Applicant Zeus Scientific, Inc.

PMA Number P150045

Class 3

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PMA 2017-09-19

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM

Applicant Zeus Scientific, Inc.

PMA Number P150042

Class 3

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PMA 2017-09-11

Stimulator, bone growth, non-invasive

Applicant Bioventus, LLC

PMA Number P900009

Class 3

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PMA 2017-09-08

Device, impotence, mechanical/hydraulic

Applicant Coloplast Corp.

PMA Number P000006

Class 3

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PMA 2017-09-07

Automated breast ultrasound

Applicant GE Healthcare

PMA Number P110006

Class 3

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PMA 2017-09-01

Cytomegalovirus (cmv) dna quantitative assay

Applicant Abbott Molecular

PMA Number P160044

Class 2

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PMA 2017-09-01

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

Applicant Ortho-Clinical Diagnostics

PMA Number P030024

Class 2

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PMA 2017-08-29

Acid, hyaluronic, intraarticular

Applicant Bioventus, LLC

PMA Number P170007

Class 3

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PMA 2017-08-25

Drug-coated peripheral transluminal angioplasty catheter

Applicant Lutonix

PMA Number P170003

Class 3

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