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 2016-10-18

Hepatitis Viral B DNA Detection

Applicant Roche Molecular Systems, Inc.

PMA Number P050028

Class 2

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PMA 2016-10-18

Immunohistochemistry assay, antibody, programmed death-ligand 1

Applicant Ventana Medical Systems, Inc.

PMA Number P160006

Class 3

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PMA 2016-10-18

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

Applicant Roche Molecular Systems, Inc.

PMA Number P060030

Class 2

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PMA 2016-10-18

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Terumo Medical Corporation

PMA Number P140002

Class 3

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PMA 2016-10-14

Laparoscopic contraceptive tubal occlusion device

Applicant Richard Wolf Medical Instruments Corp.

PMA Number P870080

Class 3

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PMA 2016-10-14

heart-valve, non-allograft tissue

Applicant ABBOTT MEDICAL

PMA Number P040021

Class 3

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PMA 2016-10-14

Lipoprotein, low density, removal

Applicant Kaneka Pharma America Corp.

PMA Number P910018

Class 3

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PMA 2016-10-13

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Bolton Medical, Inc.

PMA Number P110038

Class 3

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PMA 2016-10-13

DEVICE, ANGIOPLASTY, LASER, CORONARY

Applicant Spectranetics Corp.

PMA Number P910001

Class 3

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PMA 2016-10-12

Artificial heart

Applicant Syncardia Systems, LLC

PMA Number P030011

Class 3

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PMA 2016-10-11

Prosthesis, spinous process spacer/plate

Applicant Boston Scientific Neuromodulation

PMA Number P140004

Class 3

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PMA 2016-10-11

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Obtech Medical GmbH

PMA Number P070009

Class 3

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