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 2017-01-26

Ring, endocapsular

Applicant Morcher GmbH

PMA Number P010059

Class 3

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PMA 2017-01-12

Automated external defibrillators (non-wearable)

Applicant Heartsine Technologies, Ltd.

PMA Number P160008

Class 3

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PMA 2017-01-11

Analyzer, medical image

Applicant Icad, Inc.

PMA Number P100005

Class 2

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PMA 2017-01-10

Digital breast tomosynthesis

Applicant Fujifilm Medical Systems U.S.A, Inc.

PMA Number P160031

Class 3

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PMA 2017-01-06

Gastric Emptying Breath Test

Applicant Advanced Breath Diagnostics

PMA Number P110015

Class 3

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PMA 2016-12-30

heart-valve, non-allograft tissue

Applicant ABBOTT MEDICAL

PMA Number P100029

Class 3

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PMA 2016-12-29

Lenses, soft contact, extended wear

Applicant CooperVision, Inc.

PMA Number P080011

Class 3

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PMA 2016-12-28

Stent, superficial femoral artery, drug-eluting

Applicant Cook Ireland, Ltd.

PMA Number P100022

Class 3

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PMA 2016-12-28

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Nevro Corporation

PMA Number P130022

Class 3

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PMA 2016-12-28

Prosthesis, breast, noninflatable, internal, silicone gel-filled

Applicant Allergan

PMA Number P020056

Class 3

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PMA 2016-12-27

Implant, corneal, refractive

Applicant Rvo 2.0, Inc. (D.B.A. Optics Medical)

PMA Number P150034

Class 3

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PMA 2016-12-27

Sensor, glucose, invasive

Applicant Medtronic Minimed

PMA Number P150019

Class 3

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