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 2017-11-15

Cytomegalovirus (cmv) dna quantitative assay

Applicant Qiagen, Inc.

PMA Number P130027

Class 2

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PMA 2017-11-13

Acid, hyaluronic, intraarticular

Applicant Channel-Markers Medical, LLC

PMA Number P160057

Class 3

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PMA 2017-11-06

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Biotronik AG

PMA Number P160025

Class 3

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PMA 2017-11-03

Prostrate cancer genes nucleic acid amplification test system

Applicant Gen-Probe Incorporated

PMA Number P100033

Class 3

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PMA 2017-10-26

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

Applicant Ortho-Clinical Diagnostics, Inc.

PMA Number P090028

Class 2

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PMA 2017-10-24

Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Applicant Beckman Coulter, Inc.

PMA Number P970038

Class 3

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PMA 2017-10-24

P2psa

Applicant Beckman Coulter, Inc.

PMA Number P090026

Class 3

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PMA 2017-10-23

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Applicant The Spectranetics Corp.

PMA Number P160049

Class 3

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PMA 2017-10-20

Prosthesis, intervertebral disc

Applicant Centinel Spine, LLC

PMA Number P070001

Class 3

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PMA 2017-10-19

Implant, dermal, for aesthetic use

Applicant Teoxane S.A.

PMA Number P170002

Class 3

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PMA 2017-10-13

Iliac covered stent, arterial

Applicant Bard Peripheral Vascular, Inc.

PMA Number P160024

Class 3

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PMA 2017-10-12

Ventricular (assist) bypass

Applicant ABBOTT MEDICAL

PMA Number P160054

Class 3

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