FDA PMA Approvals

Neurovascular Liquid Embolic Agent

Applicant Balt USA, LLC

PMA Number P250009

Class 3

Cardiac ablation percutaneous catheter

Applicant Stereotaxis, Inc.

PMA Number P240014

Class 3

Cranial electrotherapy stimulator to treat depression

Applicant Neurolief , Ltd.

PMA Number P250010

Class 3

Prosthesis, mitral valve, percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P250019

Class 3

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Applicant ABBOTT MEDICAL

PMA Number P250022

Class 3

Stimulator, tibial, electrical, implantable, for urinary incontinence

Applicant Medtronic Neuromodulation

PMA Number P240011

Class 3

Implant, dermal, for aesthetic use

Applicant Symatese

PMA Number P240022

Class 3

Stent, vena cava

Applicant W. L. Gore & Associates, Inc.

PMA Number P250017

Embolization Agent, Vascular

Applicant Instylla, Inc.

PMA Number P250003

Class 3

Prosthesis, finger, semi-constrained, metal/polymer

Applicant Keri Medical SA

PMA Number P240020

Class 3

Transdermal test for Assessment of Glomerular Filtration Rate

Applicant Medibeacon, Inc.

PMA Number P230019

Class 3

Leadless Cardiac Resynchronization Therapy (CRT)

Applicant EBR Systems, Inc.

PMA Number P240028

Class 3