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 2016-05-17

Prosthesis, intervertebral disc

Applicant Globus Medical, Inc.

PMA Number P100003

Class 3

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PMA 2016-05-16

Agent, absorbable hemostatic, collagen based

Applicant Ferrosan Meidcal Devices A/S

PMA Number P990004

Class 3

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PMA 2016-05-16

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Applicant Bard Peripheral Vascular

PMA Number P060002

Class 3

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PMA 2016-05-12

Device, hemostasis, vascular

Applicant Terumo Medical Corporation

PMA Number P930038

Class 3

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PMA 2016-05-12

Digital breast tomosynthesis

Applicant Siemens Medical Solutions USA, Inc.

PMA Number P140011

Class 3

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PMA 2016-05-09

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Cordis US Corporation

PMA Number P120002

Class 3

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PMA 2016-05-05

System, photopheresis, extracorporeal

Applicant Therakos Development Limited

PMA Number P860003

Class 3

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PMA 2016-05-03

Implant, hearing, active, middle ear, partially implanted

Applicant Ototronix, LLC

PMA Number P010023

Class 3

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PMA 2016-04-26

Analyzer, medical image

Applicant Hologic, Inc.

PMA Number P970058

Class 2

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PMA 2016-04-21

Implant, dermal, for aesthetic use

Applicant Tiger Aesthetics Medical, LLC

PMA Number P020012

Class 3

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PMA 2016-04-15

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Qiagen Gaithersburg, Inc.

PMA Number P890064

Class 3

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PMA 2016-04-13

SYSTEM, TEST, HER-2/NEU, IHC

Applicant Ventana Medical Systems, Inc.

PMA Number P990081

Class 3

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