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 2016-10-21

Immunohistochemistry assay, antibody, anaplastic lymphoma kinase

Applicant Ventana Medical Systems, Inc.

PMA Number P140025

Class 3

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PMA 2016-10-20

intraocular lens

Applicant Lenstec, Inc.

PMA Number P090022

Class 3

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PMA 2016-10-20

Sealant, polymerizing

Applicant Neomend, Inc.

PMA Number P010047

Class 3

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PMA 2016-10-20

IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX

Applicant Torax Medical

PMA Number P100049

Class 3

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PMA 2016-10-19

Somatic gene mutation detection system

Applicant Roche Molecular Systems, Inc.

PMA Number P140023

Class 3

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PMA 2016-10-19

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

Applicant Siemens Healthcare Diagnostics

PMA Number P000021

Class 3

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PMA 2016-10-19

Somatic gene mutation detection system

Applicant Roche

PMA Number P120019

Class 3

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PMA 2016-10-19

Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Applicant Siemens Healthcare Diagnostics

PMA Number P020027

Class 3

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PMA 2016-10-19

Somatic gene mutation detection system

Applicant Roche Molecular Systems, Inc.

PMA Number P150047

Class 3

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PMA 2016-10-18

Cytomegalovirus (cmv) dna quantitative assay

Applicant Roche Molecular Systems, Inc.

PMA Number P110037

Class 2

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PMA 2016-10-18

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Siemens Healthcare Diagnostics

PMA Number P090024

Class 2

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PMA 2016-10-18

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Roche Molecular Systems, Inc.

PMA Number P100020

Class 3

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