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 2016-12-23

VENTILATOR, HIGH FREQUENCY

Applicant Bunnell, Inc.

PMA Number P850064

Class 3

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PMA 2016-12-23

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Applicant Boston Scientific

PMA Number P020025

Class 3

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PMA 2016-12-22

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P960040

Class 3

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PMA 2016-12-22

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Medtronic Neuromodulation

PMA Number P840001

Class 3

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PMA 2016-12-22

Implanted electrical device intended for treatment of fecal incontinence

Applicant Medtronic Neuromodulation

PMA Number P080025

Class 3

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PMA 2016-12-22

Stimulator, hypoglossal nerve, implanted, apnea

Applicant Inspire Medical Systems

PMA Number P130008

Class 3

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PMA 2016-12-22

System, hemodynamic, implantable

Applicant ABBOTT MEDICAL

PMA Number P100045

Class 3

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PMA 2016-12-22

Device, incontinence, mechanical/hydraulic

Applicant Boston Scientific Corp

PMA Number P000053

Class 3

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PMA 2016-12-22

Prosthesis, penis, inflatable

Applicant Boston Scientific Corp

PMA Number N970012

Class 3

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PMA 2016-12-22

neuromodulator for obesity

Applicant Reshape Lifesciences, Inc.

PMA Number P130019

Class 3

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PMA 2016-12-22

Lens, multifocal intraocular

Applicant Alcon Research, Ltd.

PMA Number P040020

Class 3

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PMA 2016-12-22

Stimulator, electrical, implantable, for incontinence

Applicant Medtronic Neuromodulation

PMA Number P970004

Class 3

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