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 2016-09-12

Pulmonary valve prosthesis percutaneously delivered

Applicant Medtronic, Inc.

PMA Number P140017

Class f

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PMA 2016-09-09

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant Siemens Healthcare Diagnostics

PMA Number P030056

Class 2

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PMA 2016-09-09

AID, SURGICAL, VISCOELASTIC

Applicant Alcon Laboratories

PMA Number P990023

Class 3

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PMA 2016-09-08

Cardiac ablation percutaneous catheter

Applicant St Jude Medical

PMA Number P960016

Class 3

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PMA 2016-09-08

Lenses, soft contact, extended wear

Applicant Alcon Laboratories, Inc.

PMA Number P010019

Class 3

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PMA 2016-09-08

Glue, surgical, arteries

Applicant Cryolife, Inc.

PMA Number P010003

Class 3

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PMA 2016-09-08

System, test, tumor marker, for detection of bladder cancer

Applicant Abbott Diagnostics Scarborough, Inc.

PMA Number P940035

Class 3

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PMA 2016-09-08

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant St Jude Medical

PMA Number P130026

Class 3

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PMA 2016-09-08

Cardiac ablation percutaneous catheter

Applicant Irvine Biomedical, Inc.

PMA Number P040014

Class 3

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PMA 2016-09-08

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Applicant Irvine Biomedical, Inc.

PMA Number P060019

Class 3

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PMA 2016-09-08

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Applicant Irvine Biomedical,Inc.(Ibi)

PMA Number P040042

Class 3

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PMA 2016-09-07

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P120022

Class 3

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