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 2016-04-13

STENT, ILIAC

Applicant Biotronik AG

PMA Number P140030

Class 3

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PMA 2016-04-13

Immunohistochemistry antibody assay, c-kit

Applicant Ventana Medical Systems, Inc.

PMA Number P020055

Class 3

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PMA 2016-04-12

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 2016-04-11

Fluorescence in situ hybridization, chromosome 17p deletion (TP53)

Applicant Abbott Molecular, Inc.

PMA Number P150041

Class 3

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PMA 2016-04-06

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Applicant Carbon Medical Technologies, Inc.

PMA Number P980053

Class 3

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PMA 2016-04-05

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Medtronic Vascular

PMA Number P070007

Class 3

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PMA 2016-04-04

Tissue graft of 6mm and greater

Applicant LeMaitre Vascular, Inc.

PMA Number N16837

Class 3

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PMA 2016-04-01

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant Cardiofocus, Inc.

PMA Number P150026

Class 3

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PMA 2016-03-31

Intracranial aneurysm flow diverter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

PMA Number P100018

Class 3

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PMA 2016-03-30

Diagnostic low electric field

Applicant Dilon Medical Technologies, Ltd.

PMA Number P110014

Class 3

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PMA 2016-03-30

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

Applicant Ortho-Clinical Diagnostics, Inc.

PMA Number P000044

Class 2

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PMA 2016-03-25

Aortic stent

Applicant NuMED, Inc.

PMA Number P150028

Class 3

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