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 2018-10-25

Valve, pulmonary

Applicant Pulmonx Corporation

PMA Number P180002

Class 3

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PMA 2018-10-23

Lens, intraocular, phakic

Applicant Ophtec BV

PMA Number P030028

Class 3

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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 2018-10-06

Intracranial coil-assist stent

Applicant MicroVention, Inc.

PMA Number P170013

Class 3

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PMA 2018-10-05

Bronchial thermoplasty system

Applicant Boston Scientific Corp

PMA Number P080032

Class 3

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PMA 2018-10-04

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Veryan Medical, Ltd.

PMA Number P180003

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 2018-09-19

Device, hemostasis, vascular

Applicant Morris Innovative Research, Inc.

PMA Number P050043

Class 3

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PMA 2018-09-13

CATHETER, PERCUTANEOUS (VALVULOPLASTY)

Applicant Toray Industries (America), Inc.

PMA Number P910054

Class 3

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PMA 2018-09-04

Prosthesis, testicular

Applicant Coloplast Corp.

PMA Number P020003

Class 3

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PMA 2018-08-27

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Applicant C.R. Bard, Inc.

PMA Number P170042

Class 3

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PMA 2018-08-14

Acute coronary syndrome event detector

Applicant Avertix Medical, Inc.

PMA Number P150009

Class 3

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