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 2016-11-16

Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

Applicant Zimmer, Inc.

PMA Number P060037

Class 3

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PMA 2016-11-15

Lipoprotein, low density, removal

Applicant B. Braun Avitum AG

PMA Number P940016

Class 3

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PMA 2016-11-14

Barrier, absorbable, adhesion

Applicant Baxter Healthcare Corporation

PMA Number P950034

Class 3

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PMA 2016-11-14

Excimer laser system

Applicant Amo Manufacturing USA, LLC

PMA Number P930016

Class 3

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PMA 2016-11-10

Device, hemostasis, vascular

Applicant Rex Medical, L.P.

PMA Number P150022

Class 3

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PMA 2016-11-10

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

Applicant Abbott Laboratories

PMA Number P110029

Class 2

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PMA 2016-11-10

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant Roche Diagnostics Operations, Inc.

PMA Number P140021

Class 2

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PMA 2016-11-09

Device, thermal ablation, endometrial

Applicant Axora Medical, Inc.

PMA Number P140013

Class 3

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PMA 2016-11-09

Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing

Applicant Biomet Manufacturing Corp

PMA Number P010014

Class 3

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PMA 2016-11-09

Analyzer, medical image

Applicant Qview Medical, Inc.

PMA Number P150043

Class 2

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PMA 2016-11-09

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Applicant Beckman Coulter, Inc.

PMA Number P850048

Class 3

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PMA 2016-11-08

Acid, hyaluronic, intraarticular

Applicant Sanofi Genzyme Corp.

PMA Number P940015

Class 3

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