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 2016-12-27

Lenses, soft contact, extended wear

Applicant Bausch & Lomb, Inc.

PMA Number N16895

Class 3

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PMA 2016-12-27

Automated insulin dosing device system, single hormonal control

Applicant Medtronic Minimed, Inc.

PMA Number P160017

Class 3

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PMA 2016-12-27

Automated insulin dosing , threshold suspend

Applicant Medtronic, Inc.

PMA Number P120010

Class 3

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PMA 2016-12-27

Automated insulin dosing , threshold suspend

Applicant Medtronic Minimed

PMA Number P150001

Class 3

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PMA 2016-12-27

Sensor, glucose, invasive

Applicant Medtronic Minimed

PMA Number P150029

Class 3

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PMA 2016-12-25

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

Applicant Siemens Healthcare Diagnostics

PMA Number P030040

Class 2

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PMA 2016-12-23

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

Applicant Abbott Molecular, Inc.

PMA Number P100017

Class 2

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PMA 2016-12-23

Cardiac ablation percutaneous catheter

Applicant Boston Scientific Corp

PMA Number P920047

Class 3

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PMA 2016-12-23

Assay, genotyping, hepatitis c virus

Applicant Abbott Molecular

PMA Number P120012

Class 2

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PMA 2016-12-23

Hepatitis Viral B DNA Detection

Applicant Abbott Molecular, Inc.

PMA Number P080026

Class 2

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PMA 2016-12-23

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

Applicant Roche Diagnostics, Inc.

PMA Number P160019

Class 2

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PMA 2016-12-23

Stent, carotid

Applicant Abbott Vascular

PMA Number P040012

Class 3

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