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 2017-08-15

Iliac covered stent, arterial

Applicant W. L. Gore & Associates, Inc.

PMA Number P160021

Class 3

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PMA 2017-08-10

STENT, CORONARY

Applicant Poseidon Medical, Inc.

PMA Number P150039

Class 3

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PMA 2017-08-09

intraocular lens

Applicant Carl Zeiss Meditec Production, LLC

PMA Number P100016

Class 3

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PMA 2017-08-04

Finger semi-constrained pyrolytic carbon uncemented prosthesis

Applicant Smith & Nephew, Inc.

PMA Number P000057

Class 3

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PMA 2017-08-04

Lens, intraocular, phakic

Applicant STAAR Surgical Company

PMA Number P030016

Class 3

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PMA 2017-08-04

intraocular lens

Applicant Starr Surgical Co.

PMA Number P990013

Class 3

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PMA 2017-08-04

Immunohistochemistry assay, antibody, programmed death-ligand 1

Applicant Ventana Medical Systems, Inc.

PMA Number P160046

Class 3

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PMA 2017-08-02

Ventricular (assist) bypass

Applicant Berlin Heart, Inc.

PMA Number P160035

Class 3

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PMA 2017-08-01

Somatic gene mutation detection system

Applicant Abbott Molecular, Inc.

PMA Number P170005

Class 3

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PMA 2017-07-28

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Cook Medical Incorporated

PMA Number P140016

Class 3

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PMA 2017-07-27

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

Applicant Siemens Healthcare Diagnostics

PMA Number P950021

Class 3

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PMA 2017-07-27

Tissue adhesive for internal use

Applicant Cohera Medical, Inc.

PMA Number P130023

Class 3

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