Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 2019-04-03

Prosthesis, intervertebral disc

Applicant Nuvasive, Inc.

PMA Number P100012

Class 3

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PMA 2019-03-18

Stent, carotid

Applicant W. L. Gore & Associates, Inc.

PMA Number P180010

Class 3

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PMA 2019-03-13

Immunohistochemistry assay, antibody, epidermal growth factor receptor

Applicant Agilent Technologies, Inc.

PMA Number P030044

Class 3

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PMA 2019-02-28

intraocular lens

Applicant Bausch & Lomb, Inc.

PMA Number P880090

Class 3

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PMA 2019-02-15

neuromodulator for obesity

Applicant Reshape Lifesciences, Inc.

PMA Number P130019

Class 3

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PMA 2019-02-12

Implantable pulse generator, pacemaker (non-CRT)

Applicant Biotronik, Inc.

PMA Number P820076

Class 3

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PMA 2019-01-30

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Applicant Opko Diagnostics, LLC

PMA Number P170037

Class 3

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PMA 2018-11-23

Lenses, soft contact, extended wear

Applicant CooperVision, Inc.

PMA Number N17679

Class 3

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PMA 2018-11-21

System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy

Applicant Medifocus, Inc.

PMA Number P030006

Class 3

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PMA 2018-11-15

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Hologic, Inc.

PMA Number P080014

Class 3

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PMA 2018-11-15

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Hologic, Inc.

PMA Number P080015

Class 3

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PMA 2018-10-11

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

Applicant Bard Peripheral Vascular

PMA Number P060002

Class 3

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