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 2018-10-10

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant William Cook Europe Aps

PMA Number P070016

Class 3

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PMA 2018-10-01

Device, hemostasis, vascular

Applicant Rex Medical, L.P.

PMA Number P150022

Class 3

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PMA 2018-09-28

Tissue graft of 6mm and greater

Applicant LeMaitre Vascular, Inc.

PMA Number P020049

Class 3

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PMA 2018-09-26

Cytomegalovirus (cmv) dna quantitative assay

Applicant Qiagen, Inc.

PMA Number P130027

Class 2

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PMA 2018-09-19

Device, hemostasis, vascular

Applicant Morris Innovative Research, Inc.

PMA Number P050043

Class 3

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PMA 2018-08-16

Ablation system, high intensity focused ultrasound (HIFU), MR-guided

Applicant Insightec

PMA Number P110039

Class 3

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PMA 2018-07-11

Pump, infusion, insulin, to be used with invasive glucose sensor

Applicant Animas Corp.

PMA Number P130007

Class 3

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PMA 2018-07-11

Device, thermal ablation, endometrial

Applicant CooperSurgical, Inc.

PMA Number P000032

Class 3

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PMA 2018-05-31

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Boston Scientific Corporation

PMA Number P140012

Class 3

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PMA 2018-05-30

Absorbable coronary drug-eluting stent

Applicant Abbott Vascular, Inc.

PMA Number P150023

Class 3

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PMA 2018-04-09

Transcervical contraceptive tubal occlusion device

Applicant Bayer Pharma AG

PMA Number P020014

Class 3

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PMA 2018-04-06

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Foundation Medicine, Inc.

PMA Number P160018

Class 3

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