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 2016-03-24

SYSTEM, ESOPHAGEAL PACING

Applicant Cardiocommand, Inc.

PMA Number P840002

Class 3

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PMA 2016-03-24

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant Abbott Laboratories, Inc.

PMA Number P050042

Class 2

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PMA 2016-03-22

Aortic valve, prosthesis, percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P110021

Class 3

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PMA 2016-03-22

Aortic valve, prosthesis, percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P100041

Class 3

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PMA 2016-03-18

Filler, bone void, synthetic peptide

Applicant Cerapedics, LLC

PMA Number P140019

Class 3

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PMA 2016-03-16

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant Roche Diagnostics Corp.

PMA Number P090009

Class 2

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PMA 2016-03-16

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant Roche Diagnostics Corp.

PMA Number P090007

Class 2

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PMA 2016-03-16

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant Roche Diagnostics Corp.

PMA Number P090008

Class 2

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PMA 2016-03-15

Computer-assisted personalized sedation system

Applicant Scott Laboratories, Inc.

PMA Number P080009

Class 3

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PMA 2016-03-09

Separator for therapeutic purposes, membrane automated blood cell/plasma

Applicant Asahi Kasei Medical Co., Ltd.

PMA Number P820033

Class 3

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PMA 2016-03-09

Lenses, soft contact, extended wear

Applicant CooperVision, Inc.

PMA Number P850079

Class 3

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PMA 2016-03-04

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Applicant Howmedica Osteonics Corp.

PMA Number P000013

Class 3

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