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 2019-12-02

Stent, iliac vein

Applicant Boston Scientific Corporation

PMA Number P180013

Class 3

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PMA 2019-11-29

Prosthesis, ankle, uncemented, non-constrained

Applicant Dt Medtech, LLC

PMA Number P160036

Class 3

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PMA 2019-11-26

Over-the-counter automated external defibrillator

Applicant Philips Medical Systems, Inc.

PMA Number P160029

Class 3

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PMA 2019-11-26

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS

Applicant DiaSorin, Inc.

PMA Number P180047

Class 3

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PMA 2019-11-25

Tympanostomy tube delivery product with drug

Applicant Tusker Medical, Inc.

PMA Number P190016

Class 3

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PMA 2019-11-21

Drug-coated peripheral transluminal angioplasty catheter

Applicant Medtronic Vascular, Inc.

PMA Number P190008

Class 3

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PMA 2019-11-15

Daily wear soft contact lens to reduce the progression of myopia

Applicant CooperVision, Inc.

PMA Number P180035

Class 3

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PMA 2019-11-13

Stimulator, electrical, implantable, for incontinence

Applicant Boston Scientific Corporation

PMA Number P180046

Class 3

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PMA 2019-11-06

Lens, contact, orthokeratology, overnight

Applicant Menicon Co, Ltd.

PMA Number P990018

Class 3

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PMA 2019-11-04

implanted diaphragmatic/phrenic nerve Stimulator

Applicant Avery Biomedical Devices, Inc.

PMA Number P860026

Class 3

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PMA 2019-10-29

Normothermic preservation system for transplantation of initially unacceptable donor lungs

Applicant Xvivo Perfusion, Inc.

PMA Number P180014

Class 3

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PMA 2019-10-25

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

Applicant Siemens Healthcare Diagnostics

PMA Number P030049

Class 2

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