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 2017-05-16

Immunohistochemistry antibody assay, c-kit

Applicant Dako North America, Inc.

PMA Number P040011

Class 3

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PMA 2017-04-12

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

Applicant Dako Denmark A/S

PMA Number P100024

Class 3

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PMA 2017-04-12

SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM

Applicant Agilent Technologies Singapore (International) Pte , Ltd.

PMA Number P040005

Class 3

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PMA 2017-04-03

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Applicant Exactech, Inc.

PMA Number P050039

Class 3

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PMA 2017-03-24

Immunohistochemistry assay, antibody, programmed death-ligand 1

Applicant Dako North America, Inc.

PMA Number P150027

Class 3

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PMA 2017-03-24

Analyzer, medical image

Applicant Icad, Inc.

PMA Number P160009

Class 2

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PMA 2017-03-02

Absorbable collagen hemostatic agent with thrombin

Applicant Stryker Corp.

PMA Number P050044

Class 3

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PMA 2017-02-01

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Medtronic Vascular

PMA Number P110040

Class 3

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PMA 2017-02-01

STENT, ILIAC

Applicant Medtronic Vascular

PMA Number P090006

Class 3

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PMA 2017-02-01

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Medtronic Vascular

PMA Number P070027

Class 3

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PMA 2017-02-01

STENT, ILIAC

Applicant Medtronic, Ireland

PMA Number P110011

Class 3

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PMA 2017-01-11

Analyzer, medical image

Applicant Icad, Inc.

PMA Number P100005

Class 2

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