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 2017-06-08

Joint, temporomandibular, implant

Applicant Biomet Microfixation, Inc.

PMA Number P020016

Class 3

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PMA 2017-06-08

Excimer laser system

Applicant Nidek Co., Ltd.

PMA Number P970053

Class 3

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PMA 2017-06-02

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Endologix, LLC

PMA Number P040002

Class 3

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PMA 2017-05-26

Automated external defibrillators (non-wearable)

Applicant ZOLL Medical Corporation

PMA Number P160015

Class 3

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PMA 2017-05-16

Immunohistochemistry assay, antibody, epidermal growth factor receptor

Applicant Agilent Technologies, Inc.

PMA Number P030044

Class 3

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PMA 2017-05-16

Immunohistochemistry antibody assay, c-kit

Applicant Dako North America, Inc.

PMA Number P040011

Class 3

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PMA 2017-04-28

Somatic gene mutation detection system

Applicant Invivoscribe Technologies, Inc.

PMA Number P160040

Class 3

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PMA 2017-04-26

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P930036

Class 3

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PMA 2017-04-14

STENT, ILIAC

Applicant Abbott Vascular, Inc.

PMA Number P110028

Class 3

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PMA 2017-04-07

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Applicant Palette Life Sciences

PMA Number P100014

Class 3

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PMA 2017-04-07

STENT, RENAL

Applicant Abbott Vascular

PMA Number P110001

Class 3

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PMA 2017-03-31

AID, SURGICAL, VISCOELASTIC

Applicant Anika Therapeutics, Inc.

PMA Number P000046

Class 3

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