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 2017-07-25

SYSTEM, TEST, HER-2/NEU, IHC

Applicant Leica Biosystems

PMA Number P090015

Class 3

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PMA 2017-07-18

Device, thermal ablation, endometrial

Applicant Hologic, Inc.

PMA Number P010013

Class 3

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PMA 2017-07-05

Agent, absorbable hemostatic, collagen based

Applicant C.R. Bard, Inc.

PMA Number P800002

Class 3

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PMA 2017-06-29

Device, thermal ablation, endometrial

Applicant Axora Medical, Inc.

PMA Number P000040

Class 3

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PMA 2017-06-29

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Illumina, Inc.

PMA Number P160038

Class 3

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PMA 2017-06-28

AID, SURGICAL, VISCOELASTIC

Applicant Bausch & Lomb, Inc.

PMA Number P860047

Class 3

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PMA 2017-06-28

AID, SURGICAL, VISCOELASTIC

Applicant Bausch & Lomb, Inc.

PMA Number P810025

Class 3

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PMA 2017-06-28

Electrical Impedance Spectrometer

Applicant Scibase AB

PMA Number P150046

Class 2

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PMA 2017-06-23

Single-use internal condom

Applicant Clear Future, Inc.

PMA Number P080002

Class 2

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PMA 2017-06-20

Prosthesis, intervertebral disc

Applicant Highridge Medical, LLC

PMA Number P120024

Class 3

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PMA 2017-06-19

SYSTEM, ESOPHAGEAL PACING

Applicant Cardio Command

PMA Number P860008

Class 3

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PMA 2017-06-14

Device, thermal ablation, endometrial

Applicant CooperSurgical, Inc.

PMA Number P160047

Class 3

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