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 2017-03-28

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

Applicant Abbott Laboratories

PMA Number P910007

Class 3

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PMA 2017-03-28

Biologic material, dental

Applicant The Straumann Company

PMA Number P930021

Class 3

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PMA 2017-03-24

STENT, CORONARY

Applicant Biotronik AG

PMA Number P160003

Class 3

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PMA 2017-03-24

Analyzer, medical image

Applicant Icad, Inc.

PMA Number P160009

Class 2

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PMA 2017-03-24

Microspheres radionuclide

Applicant Sirtex Medical, Inc.

PMA Number P990065

Class 3

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PMA 2017-03-21

STENT, CORONARY

Applicant Abbott Vascular, Inc.

PMA Number P970020

Class 3

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PMA 2017-03-14

Assay, genotyping, hepatitis c virus

Applicant Fujirebio Europe N.V.

PMA Number P160016

Class 2

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PMA 2017-03-09

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM

Applicant Diasorin

PMA Number P970055

Class 3

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PMA 2017-03-03

HEART-VALVE, MECHANICAL

Applicant Corcym S.r.l.

PMA Number P900060

Class 3

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PMA 2017-03-02

Absorbable collagen hemostatic agent with thrombin

Applicant Stryker Corp.

PMA Number P050044

Class 3

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PMA 2017-02-21

STENT, CORONARY

Applicant Celonova Biosciences, Inc.

PMA Number P160014

Class 3

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PMA 2017-02-13

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

Applicant Hologic, Inc.

PMA Number P160023

Class 2

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