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 2016-08-10

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Medtronic Vascular

PMA Number P100021

Class 3

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PMA 2016-08-10

STENT, ILIAC

Applicant Medtronic Vascular

PMA Number P090006

Class 3

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PMA 2016-08-10

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Medtronic Vascular

PMA Number P070027

Class 3

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PMA 2016-08-10

STENT, ILIAC

Applicant Medtronic, Ireland

PMA Number P110011

Class 3

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PMA 2016-08-09

Mitral valve repair devices

Applicant ABBOTT MEDICAL

PMA Number P100009

Class 3

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PMA 2016-08-09

Prosthesis, finger, constrained, metal/polymer

Applicant Stryker Corporation

PMA Number P960053

Class 3

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PMA 2016-08-08

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

Applicant Roche Diagnostics Corp.

PMA Number P100032

Class 2

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PMA 2016-08-08

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

Applicant Roche Diagnostics Corp.

PMA Number P100031

Class 2

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PMA 2016-08-04

OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Applicant ABBOTT MEDICAL

PMA Number P020024

Class 3

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PMA 2016-08-04

Cardiac ablation percutaneous catheter

Applicant Biosense Webster, Inc.

PMA Number P990071

Class 3

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PMA 2016-08-04

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

Applicant Roche Molecular Systems, Inc.

PMA Number P000012

Class 2

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PMA 2016-08-04

Transcatheter septal occluder

Applicant ABBOTT MEDICAL

PMA Number P000039

Class 3

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