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 2016-08-20

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

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P100039

Class 2

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PMA 2016-08-19

intraocular lens

Applicant Rayner Intraocular Lenses , Ltd.

PMA Number P060011

Class 3

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PMA 2016-08-19

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Nuvectra Corporation

PMA Number P130028

Class 3

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PMA 2016-08-18

Optical diagnostic device for melanoma detection

Applicant Strata Skin Sciences, Inc.

PMA Number P090012

Class 2

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PMA 2016-08-12

heart-valve, non-allograft tissue

Applicant Edwards Lifesciences, LLC

PMA Number P150036

Class 3

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PMA 2016-08-11

Prosthesis, intervertebral disc

Applicant Medtronic Sofamor Danek, Inc.

PMA Number P060018

Class 3

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PMA 2016-08-11

Prosthesis, intervertebral disc

Applicant Companion Spine France Sas

PMA Number P060023

Class 3

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PMA 2016-08-11

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

Applicant Siemens Healthcare Diagnostics

PMA Number P040004

Class 2

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PMA 2016-08-11

STENT, ILIAC

Applicant Boston Scientific Corporation

PMA Number P090003

Class 3

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PMA 2016-08-10

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Medtronic Vascular

PMA Number P110040

Class 3

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PMA 2016-08-10

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Medtronic Vascular

PMA Number P100040

Class 3

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PMA 2016-08-10

STENT, CORONARY

Applicant Boston Scientific Scimed, Inc.

PMA Number P020009

Class 3

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