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 2020-04-15

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P190026

Class 3

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PMA 2020-04-13

Lenses, soft contact, extended wear

Applicant Bausch & Lomb, Inc.

PMA Number P960022

Class 3

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PMA 2020-02-18

Test, urea adult and pediatric (breath),

Applicant Arj Medical, Inc.

PMA Number P170022

Class 3

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PMA 2019-12-19

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

Applicant Siemens Healthcare Diagnostics Products, Ltd.

PMA Number P010053

Class 2

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PMA 2019-12-19

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

Applicant Siemens Healthcare Diagnostics Products, Ltd.

PMA Number P010051

Class 2

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PMA 2019-12-19

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

Applicant Siemens Healthcare Diagnostics Products, Ltd.

PMA Number P010050

Class 2

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PMA 2019-12-19

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

Applicant Siemens Healthcare Diagnostics Products, Ltd.

PMA Number P010052

Class 2

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PMA 2019-12-17

Aortic valve, prosthesis, percutaneously delivered

Applicant Boston Scientific Corporation

PMA Number P180029

Class 3

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PMA 2019-12-16

Intracranial aneurysm flow diverter

Applicant MicroVention, Inc.

PMA Number P180027

Class 3

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PMA 2019-12-12

Implanted electrical device intended for treatment of fecal incontinence

Applicant Boston Scientific Corporation

PMA Number P190006

Class 3

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PMA 2019-12-06

Ventricular (assist) bypass

Applicant Abbott

PMA Number P170038

Class 3

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PMA 2019-12-04

Coronary drug-eluting stent

Applicant Biotronik AG

PMA Number P170030

Class 3

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